40 registrations that name leuprorelin as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 40 registrations
Status
Phase
789US sites across 51 states
1
2 to 4
5 to 19
20 or more
All 40 registrations
RecruitingNCT04423211
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
Phase 3
ECOG-ACRIN Cancer Research Group
About 804 people
Started Oct 8, 2020
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by ECOG-ACRIN Cancer Research Group. It plans to enroll about 804 people at 341 US sites.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8.
STEP 0: REGISTRATION ELIGIBILITY CRITERIA
Patient must be male and >= 18 years of age.
Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
Patient must have biochemical recurrence (BCR) after RP, defined as follows:
32 more inclusion criteria and the exclusion criteria are on the listing.
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer). The full summary is on the listing.
Where, as registered
341 US sites in 34 states.
RecruitingNCT03678025
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Phase 3
SWOG Cancer Research Network
About 1,273 people
Started Sep 24, 2018
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by SWOG Cancer Research Network. It plans to enroll about 1,273 people at 338 sites, 334 of them in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Castration Levels of Testosterone; Metastatic Prostatic Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8.
STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate.
STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\], cryotherapy, laser…
STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic…
STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis.
20 more inclusion criteria and the exclusion criteria are on the listing.
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
Where, as registered
334 US sites in 43 states; also Chile (1), Colombia (1), Mexico (1), Switzerland (1).
RecruitingNCT05827081
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Phase 3
Novartis Pharmaceuticals
About 1,444 people
Started Feb 28, 2024
In plain words A Phase 3 study of leuprorelin in people 18 to 100, run by Novartis Pharmaceuticals. It plans to enroll about 1,444 people at 229 sites, 85 of them in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 100. Conditions: Early Breast Cancer.
Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).
Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory…
Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+.
Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and…
18 more inclusion criteria and the exclusion criteria are on the listing.
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Where, as registered
85 US sites in 38 states; also Germany (29), China (24), Turkey (Türkiye) (20), South Korea (12), Canada (11), Brazil (10), India (9), Portugal (6), Taiwan (5), Australia (4), Israel (4), Argentina (3), Hong Kong (3), Mexico (3), Puerto Rico (1).
RecruitingNCT01492972
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
Phase 3
Proton Collaborative Group
About 192 people
Started Jan 2012
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by Proton Collaborative Group. It plans to enroll about 192 people at 4 US sites.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer.
Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Radiation; Androgen Suppression Therapy
Registered summary
The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
Where, as registered
4 US sites in 4 states.
RecruitingNCT06650579
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Phase 3
Emory University
About 72 people
Started Jan 31, 2025
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by Emory University. It plans to enroll about 72 people at 4 US sites.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Recurrent Prostate Carcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8.
Men ≥ 18 years old
Non-metastatic prostate cancer
Non-metastatic, biochemically recurrent prostate cancer
Plan to undergo curative-intent pelvic radiation therapy (photons or protons) with or without brachytherapy
1 more inclusion criterion and the exclusion criteria are on the listing.
This phase III/IV trial compares the impact of leuprolide and abiraterone acetate (AA) versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy. Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists (GNRHa). It prevents the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate tumor cells that need testosterone to grow. The full summary is on the listing.
Where, as registered
4 US sites in 1 state.
RecruitingNCT06378866
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
Phase 2
Mayo Clinic
About 532 people
Started Jun 3, 2024
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Mayo Clinic. It plans to enroll about 532 people at 3 US sites.
This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. The full summary is on the listing.
Where, as registered
3 US sites in 3 states.
RecruitingNCT05765500
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Phase 2
Dana-Farber Cancer Institute
About 110 people
Started Feb 12, 2024
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Dana-Farber Cancer Institute. It plans to enroll about 110 people at 3 US sites.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer; Prostatic Neoplasms.
Participants must have a histologic diagnosis of prostate adenocarcinoma.
Participants must be eligible for treatment with 6 months of ADT with leuprolide depot or relugolix without additional systemic therapies other than first generation androgen receptor antagonists (eg. bicalutamide, nilutamide, flutamide).
Participants cannot have received prior GnRH agonist or antagonist therapy.
Patients must have testosterone level > 200 ng/mL prior to initiation of ADT.
18 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Relugolix; Leuprolide
Registered summary
This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label. The names of the study drugs involved in this study are: * Leuprolide (type of ADT) * Relugolix (type of ADT)
Where, as registered
3 US sites in 1 state.
RecruitingNCT06397703
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
Phase 2
NYU Langone Health
About 392 people
Started Apr 16, 2024
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by NYU Langone Health. It plans to enroll about 392 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer.
Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7;…
Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
At least 4 weeks must have elapsed from major surgery
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Leuprolide, Degarelix or Relugolix; Stereotactic body radiation therapy/radiosurgery (SBRT)
Registered summary
For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07650240
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
Phase 2
Mayo Clinic
About 202 people
Started Aug 4, 2026
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Mayo Clinic. It plans to enroll about 202 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Recurrent Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8; Castration-Sensitive Prostate Cancer; Metastatic Hormone-sensitive Prostate Cancer (mHSPC); Prostate Cancer; Prostate Adenocarcinoma; Adenocarcinoma of the Prostate; Localized Prostate Carcinoma; Metastatic Prostate Cancer; Metastatic Prostate Adenocarcinoma; Advanced Prostate Cancer; Advanced Prostate Adenocarcinoma.
Male patients aged 18 years or older
Signed informed consent must be obtained prior to participation in the study
Histologically confirmed adenocarcinoma of the prostate
Prior treatment with radical prostatectomy or radiation therapy for localized disease is required
19 more inclusion criteria and the exclusion criteria are on the listing.
This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07801664
Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer
Phase 2
NYU Langone Health
About 90 people
Started Aug 6, 2026
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by NYU Langone Health. It plans to enroll about 90 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer.
Ability to understand and willingness to sign a written informed consent document
18 years of age or older male participants
Biopsy proven prostate cancer meeting at least one of the following high-risk criteria: Gleason score 8-10 OR; Baseline PSA >20 up to and including 40 ng/ml OR; Patients with Gleason score 6-7 remain eligible if the PSA criterion (>20…
No imaging evidence of nodal metastases on baseline MRI/ CT of the pelvis and PET-PSMA scans
8 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Androgen Deprivation Therapy (ADT); Radiotherapy
Registered summary
For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.
Where, as registered
1 US site in 1 state.
RecruitingNCT07158021
Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
Phase 2
University of Michigan Rogel Cancer Center
About 75 people
Started Jan 22, 2026
In plain words A Phase 2 study of leuprorelin in female participants 18 and older, run by University of Michigan Rogel Cancer Center. It plans to enroll about 75 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma.
Female subject aged ≥ 18 years
Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the…
Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer.
Not planning bilateral salpingo-oophorectomy during the 6-month study duration
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Biospecimen Collection; Electronic Health Record Review; Goserelin; Leuprolide; Questionnaire Administration
Registered summary
This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT04734730
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
Phase 2
City of Hope Medical Center
About 70 people
Started May 4, 2021
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by City of Hope Medical Center. It plans to enroll about 70 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8.
All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. (Note: Gleason score not required if biopsy of metastasis was used to make the histologic diagnosis)
All patients must have metastatic disease: either soft tissue and/or bony metastases prior to initiation of androgen. Measurable disease is not required
Baseline imaging must have been performed within 42 days before or 14 days after initiating luteinizing hormone releasing hormones (LHRH) therapy. All disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients may have started on LHRH therapy for metastatic prostate cancer provided this was initiated no longer than 60 days prior to registration
17 more inclusion criteria and the exclusion criteria are on the listing.
This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Androgen can cause the growth of prostate tumor cells. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06330805
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Phase 2
Ohio State University Comprehensive Cancer Center
About 70 people
Started Aug 12, 2024
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Ohio State University Comprehensive Cancer Center. It plans to enroll about 70 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8.
Pathologically proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration.
Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
Has at least one intermediate risk factor (IRF):
Prostate-specific antigen (PSA) 10-20 ng/mL
28 more inclusion criteria and the exclusion criteria are on the listing.
This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT03541928
Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
Phase 2
The Methodist Hospital Research Institute
About 60 people
Started Aug 2, 2018
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by The Methodist Hospital Research Institute. It plans to enroll about 60 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: High-risk Prostate Cancer; Prostate Cancer.
All patients must have biopsy proven adenocarcinoma of the prostate
Patients in should have at least one or more of the following characteristics PSA>20, Gleason score 8-10, Primary Gleason pattern 5, >4 cores with Gleason 8-10, and Clinical stage T3a-T4.
No prior surgical, hormonal, or radiotherapy prostate treatment.
ECOG performance status 0-1
9 more inclusion criteria and the exclusion criteria are on the listing.
This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy in previously untreated high-risk prostate cancer.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About 60 people
Started Mar 9, 2026
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It plans to enroll about 60 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Metastatic Castration-resistant Prostate Cancer.
Age ≥ 18 years
Performance status ≤2.
Documented histologically confirmed adenocarcinoma of the prostate.
Baseline PSA ≥1.0 ng/ml.
16 more inclusion criteria and the exclusion criteria are on the listing.
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Where, as registered
1 US site in 1 state.
RecruitingNCT06059118
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About 50 people
Started Oct 4, 2023
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer.
Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.
Age ≥18 years.
Histologically-confirmed adenocarcinoma of the prostate.
Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).
26 more inclusion criteria and the exclusion criteria are on the listing.
Asymptomatic patients with metastatic castrate resistant prostate cancer (mCRPC) without pain due to prostate cancer will be treated on an open label study to evaluate effectiveness of sequential treatment with the combination of difluoromethylornithine (DFMO) and high dose testosterone in sequence with enzalutamide to improve primary and secondary outcomes.
Where, as registered
1 US site in 1 state.
RecruitingNCT06922318
The COSMYC Trial (COmbined Suppression of MYC)
Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About 50 people
Started Aug 19, 2025
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Metastatic Castration-resistant Prostate Cancer.
Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.
Age ≥18 years.
Histologically-confirmed adenocarcinoma of the prostate.
Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).
21 more inclusion criteria and the exclusion criteria are on the listing.
This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.
Where, as registered
1 US site in 1 state.
RecruitingNCT07455903
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Phase 2
Baptist Health South Florida
About 50 people
Started Jul 29, 2026
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Baptist Health South Florida. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer; Localized Prostate Carcinoma.
Signed informed consent must be obtained prior to participation in the study.
Males aged ≥18 years.
ECOG performance status ≤ 1
Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
10 more inclusion criteria and the exclusion criteria are on the listing.
The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).
Where, as registered
1 US site in 1 state.
RecruitingNCT07848828
Autonomic and Renal Contributions to Hypertension With ADT
Phase 4
Virginia Commonwealth University
About 50 people
Started Aug 1, 2026
In plain words A Phase 4 study of leuprorelin in male participants 40 and older, run by Virginia Commonwealth University. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 40 and older; healthy volunteers accepted. Conditions: Androgen Deprivation Therapy; Prostate Cancer; Hypertension; Autonomic Dysfunction; Renal Disease.
age 40+ years;
resting blood pressure <140/90 mmHg;
fasted blood glucose <126 mg/dL;
testosterone ≥400 ng/dL;
9 more inclusion criteria and the exclusion criteria are on the listing.
This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07027124
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
Phase 2
Icahn School of Medicine at Mount Sinai
About 40 people
Started May 21, 2026
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Icahn School of Medicine at Mount Sinai. It plans to enroll about 40 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer; High-risk Prostate Cancer.
Male Age ≥ 18 years at the time of consent
Subjects must have histopathologically confirmed adenocarcinoma of the prostate
Subjects must have unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of distant metastasis or non-regional nodal involvement.
Subjects must be risk-stratified at biopsy and their cancer should have all the molecular features given below at baseline.
28 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Darolutamide; Pembrolizumab; Lupron
Registered summary
This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), \[Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide\], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP). The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT05896293
Kisspeptin Administration Subcutaneously to Patients With IHH
Phase 2
Stephanie B. Seminara, MD
About 36 people
Started Feb 3, 2023
In plain words A Phase 2 study of leuprorelin in people 18 and older, run by Stephanie B. Seminara, MD. It plans to enroll about 36 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Hypogonadotropic Hypogonadism.
Congenital IHH
Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins
Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
kisspeptin 112-121; leuprolide acetate
Registered summary
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07751133
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Phase 3
University College, London
About 1,500 people
Started Aug 28, 2026
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by University College, London. It plans to enroll about 1,500 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer; mHSPC; mCRPC.
Adult males (male sex at birth) aged 18 years or older
Newly histologically or cytologically diagnosed prostate cancer (adenocarcinoma) that is metastatic hormone-sensitive (mHSPC) or metastatic castration resistant prostate cancer (mCRPC), for whom ARPI in combination with androgen…
Prior ADT use for prostate cancer (including bilateral orchidectomy and transcutaneous oestrogen), is permitted provided: (a) ADT has been started less than 12 weeks prior to randomisation in mHSPC, (b) In the adjuvant setting the…
ECOG performance status 0-2
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy
Registered summary
The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are: 1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and 2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose. The full summary is on the listing.
Where, as registered
No US site; United Kingdom (2).
RecruitingNCT05781217
Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624
Phase 3
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
About 534 people
Started Mar 14, 2023
In plain words A Phase 3 study of leuprorelin in people 18 and older, run by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic. It plans to enroll about 534 people at 17 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Prostate Cancer; Salvage Radiotherapy; Biochemical Recurrence; Androgen Deprivation Therapy; Metastases-free Survival.
Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion.
Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng/mL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than the initial value).
Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18):
Testosterone level > 150 ng/dL at inclusion
3 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
triptorelin, goserelin, leuprorelin
Registered summary
The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The full summary is on the listing.
Where, as registered
No US site; Spain (17).
RecruitingNCT06282588
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
Phase 2 and 3
Cancer Research Antwerp
About 493 people
Started Dec 13, 2023
In plain words A Phase 2 and 3 study of leuprorelin in male participants 18 and older, run by Cancer Research Antwerp. It plans to enroll about 493 people at 9 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer.
Histopathology-proven PCa
High-risk locally advanced disease is defined as any of the following factors: PSA > 20 ng/mL OR T-stage 3 or 4 OR Gleason score 8-10 OR cN1.
An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1.
Willingness to undergo a PSMA PET/ CT with or without contrast.
16 more inclusion criteria and the exclusion criteria are on the listing.
This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. The full summary is on the listing.
Where, as registered
No US site; Belgium (9).
RecruitingNCT06654336
Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)
Phase 2
Ontario Clinical Oncology Group (OCOG)
About 162 people
Started May 6, 2026
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by Ontario Clinical Oncology Group (OCOG). It plans to enroll about 162 people at 5 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Adenocarcinoma; Castration Sensitive Prostate Cancer.
Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.
Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.
All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.
Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Recurrence-directed therapy (RDT); ELIGARD 22.5mg
Registered summary
The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.
Where, as registered
No US site; Canada (5).
RecruitingNCT07159451
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris
About 140 people
Started Oct 6, 2025
In plain words A Phase 2 study of leuprorelin in female participants 18 and older, run by Gustave Roussy, Cancer Campus, Grand Paris. It plans to enroll about 140 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: Breast Cancer.
Aged 18 or more.
Signed Informed Consent Form prior to any study-specific procedure. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study…
Patients must be affiliated to a Social Security System (or equivalent).
Premenopausal women ensured by checking if the women were still having regular periods over the last 6 months without any hormonal treatment or hormonal contraception or if they were irregular, FSH and estradiol levels must fall within the…
18 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Elacestrant; Leuprorelin
Registered summary
A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery. The full summary is on the listing.
Where, as registered
No US site; France (1).
RecruitingNCT06225284
Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients
Phase 2
National Taiwan University Hospital
About 124 people
Started Aug 22, 2024
In plain words A Phase 2 study of leuprorelin in female participants 18 and older, run by National Taiwan University Hospital. It plans to enroll about 124 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: Triple Negative Breast Cancer; Premenopausal Breast Cancer.
Written informed consent must be obtained before any assessment is performed.
Female patients aged ≥ 18 years at screening; Must be premenopausal according to serum E2, FSH level.
Histological confirmed TNBC, as defined by the most recent ASCO/CAP guidelines. Hormone receptor-low/HER2 negative as defined by ER 1% to <10% and/or PR 1% to <10% on IHC staining; neither hormone receptor may be ≥ 10%; and HER2-negative…
Have previously untreated locally advanced non-metastatic (M0) TNBC and hormone receptor-low/HER2-negative defined as the following combined primary tumor (T) and regional lymph node (N) staging per current AJCC staging criteria for breast…
14 more inclusion criteria and the exclusion criteria are on the listing.
Breast cancer (BC), especially premenopausal, is emerging rapidly in East Asia in recent 20 years. Half of the breast cancer patients in Asia are younger than 50 years of age. In general, younger or premenopausal patients are associated with poorer prognosis. Premenopausal patients have higher estrogen levels than those in older (postmenopausal) patients. Estrogen is known to suppress anti-tumor T cell response and leading to tumor progression in different animal models (Clin Cancer Res 2016 22:6204), including lung cancer, melanoma, ovarian cancer. The full summary is on the listing.
Where, as registered
No US site; Taiwan (1).
RecruitingNCT05206682
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
No phase
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About 94 people
Started May 1, 2023
In plain words A study of leuprorelin in female participants 18 to 50, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. It plans to enroll about 94 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 50. Conditions: Cesarean Section; Dehiscence.
Clearly diagnosed with CSD complicated with adenomyosis
Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days).
The thickness of the remaining muscular layer of CSD was less than 3 mm.
Normal range of blood sugar and insulin
3 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Leuprorelin
Registered summary
GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect（CSD） patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed.
Where, as registered
No US site; China (1).
RecruitingNCT06512207
A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
No phase
Jinzhou Medical University
About 80 people
Started Dec 3, 2023
In plain words A study of leuprorelin in male participants 60 and older, run by Jinzhou Medical University. It plans to enroll about 80 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 60 and older. Conditions: NSCLC, Stage III; NSCLC, Stage IV.
Male patients aged ≥60 years.
ECOG performance status score of 0 ~1.
Expected survival time of more than 3 months.
Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.
9 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Leuprorelin acetate + Sintilimab; Sintilimab
Registered summary
Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.
Where, as registered
No US site; China (1).
RecruitingNCT04249154
Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer
Phase 2
McGill University Health Centre/Research Institute of the McGill University Health Centre
About 77 people
Started Sep 3, 2019
In plain words A Phase 2 study of leuprorelin in male participants 18 and older, run by McGill University Health Centre/Research Institute of the McGill University Health Centre. It plans to enroll about 77 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older; healthy volunteers accepted. Conditions: Prostate Cancer.
Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score >7) adenocarcinoma of the prostate after a radical prostatectomy as primary…
Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and…
Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed
History and physical examination (including digital rectal exam) within 90 days prior of registration
5 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Eligard
Registered summary
Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic. Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure. The full summary is on the listing.
Where, as registered
No US site; Canada (2).
RecruitingNCT05169112
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Phase 3
Ottawa Hospital Research Institute
About 72 people
Started Mar 6, 2023
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by Ottawa Hospital Research Institute. It plans to enroll about 72 people at 3 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer.
undetectable PSA (<0.02 ng/ml) within 16 weeks post-operative;
≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
The exclusion criteria are on the listing.
What it tests, as registered
Lupron Depot
Registered summary
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. The full summary is on the listing.
Where, as registered
No US site; Canada (3).
RecruitingNCT07710430
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
Phase 4
LG Chem
About 43 people
Starts Aug 1, 2026 (estimated)
In plain words A Phase 4 study of leuprorelin in people up to 10, run by LG Chem. It plans to enroll about 43 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people up to 10. Conditions: Central Precocious Puberty.
Tanner stage =>2
Girls younger than 9 years old, boys younger than 10 years old
Subjects who are diagnosed with central precocious puberty (CPP)
The exclusion criteria are on the listing.
What it tests, as registered
Leuprorelin
Registered summary
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty
Where, as registered
No US site; South Korea (1).
RecruitingNCT06145308
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Phase 2
Peking Union Medical College
About 39 people
Started Aug 15, 2023
In plain words A Phase 2 study of leuprorelin in people 18 to 100, run by Peking Union Medical College. It plans to enroll about 39 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 100. Conditions: Salivary Gland Carcinoma; Precision Therapy.
Patients with histopathologic diagnosis of salivary gland carcinoma
The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
Age 18 or older - no upper limit;
1 more inclusion criterion and the exclusion criteria are on the listing.
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.
Where, as registered
No US site; China (2).
RecruitingNCT06348264
Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
Phase 2
Peking University First Hospital
About 37 people
Started Oct 10, 2024
In plain words A Phase 2 study of leuprorelin in people 18 and older, run by Peking University First Hospital. It plans to enroll about 37 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Salivary Gland Neoplasm Duct.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Histologically confirmed salivary duct carcinoma and stage III or IVa or IVb according to AJCC Cancer Staging Manual Eighth Edition
Completed SDC surgery, and adjuvant radiotherapy is planned or ongoing or has completed
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Rezvilutamide; Leuprolide Acetate
Registered summary
The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC). The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years.
Where, as registered
No US site; China (2).
RecruitingNCT05478083
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
Phase 2
University Medical Center Groningen
About 36 people
Started Jun 1, 2022
In plain words A Phase 2 study of leuprorelin in female participants 18 to 45, run by University Medical Center Groningen. It plans to enroll about 36 people at 2 sites, none in the US.
Diagnosis of polycystic liver disease defined as the presence of more than 10 liver cysts
Age between 18 to 45 (inclusive) years;
Very large liver for age, defined as the upper 10% of liver volumes in specific age categories (based on a retrospective polycystic liver disease registry, n=1.600 patients)
10 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Leuprorelin
Registered summary
Multicenter trial on the effect of the GnRH analogue leuprorelin on the growth of total liver volume in pre-menopausal women with very severe polycystic liver disease who, despite available therapy, experience growth and are heading for liver transplantation.
Where, as registered
No US site; Netherlands (2).
RecruitingNCT07755956
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
In plain words A Phase 1 study of leuprorelin in female participants 18 to 45, run by Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.. It plans to enroll about 30 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 45. Conditions: Endometriosis.
Voluntarily provide written informed consent;
Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;
The most recent menstrual cycle 21-35 days;
Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;
2 more inclusion criteria and the exclusion criteria are on the listing.
The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits. Researchers will compare HHK001 to Enantone to test the advantages of its updated formulation.
Where, as registered
No US site; China (1).
Not yet recruitingNCT07596212
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Phase 1 and 2
University of Illinois at Chicago
About 100 people
Starts Sep 2026 (estimated)
In plain words A Phase 1 and 2 study of leuprorelin in female participants 18 and older, run by University of Illinois at Chicago. It plans to enroll about 100 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: Early-stage Breast Cancer; Hypoactive Sexual Desire Disorder; Hormone Receptor Positive Breast Carcinoma; Breast Cancer.
Females 18 or older
Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and/or progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint…
Completion of the following planned cancer treatments prior to registration:
Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)
8 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Aromatase Inhibitors; Bupropion; GnRH agonist
Registered summary
This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
Not yet recruitingNCT06855589
Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months.
Phase 3
Charles LeMoyne Hospital
About 400 people
Starts Mar 2025 (estimated)
In plain words A Phase 3 study of leuprorelin in male participants 18 and older, run by Charles LeMoyne Hospital. It plans to enroll about 400 people at 5 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists male participants 18 and older. Conditions: Prostate Cancer (Adenocarcinoma).
1\. Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization, (if longer than 6 months, needs to be approved by the central Principal Investigator).
≥ 2 of the following:
CT2b-cT2c
Gleason score 7 (3+4) or (4+3)
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
6 months of Eligard; 12 months of Eligard; prostate SBRT or prostate brachytherapy with radiation therapy
Registered summary
Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.
Where, as registered
No US site; Canada (5).
Not yet recruitingNCT07179939
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
Phase 2
Fudan University
About 288 people
Starts Sep 10, 2025 (estimated)
In plain words A Phase 2 study of leuprorelin in female participants 18 and older, run by Fudan University. It plans to enroll about 288 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: HER2-positive Breast Cancer.
Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.
Female patients ≥ 18 years of age at the time of signing ICF.
Breast Cancer Requirements:
Histologically or cytologically confirmed HER2-positive(IHC 3+ or ISH+) unresectable locally advanced or metastatic breast cancer (Note: Patients eligible for curative-intent treatment are excluded).
6 more inclusion criteria and the exclusion criteria are on the listing.
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
Where, as registered
No US site; China (1).
Not yet recruitingNCT07782840
QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy
Phase 2
Hebei Medical University Fourth Hospital
About 40 people
Starts Oct 1, 2026 (estimated)
In plain words A Phase 2 study of leuprorelin in female participants 18 to 75, run by Hebei Medical University Fourth Hospital. It plans to enroll about 40 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 75. Conditions: Breast Cancer.
Female participants aged 18 to 75 years.
Histologically or pathologically confirmed HR-positive/HER2-negative early or locally advanced breast cancer, classified as stage IIB-IIIC, with a poor response to two cycles of neoadjuvant TAC chemotherapy.
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
No prior antitumor treatment other than the two cycles of neoadjuvant TAC chemotherapy specified in this study, including no prior immune checkpoint inhibitor therapy.
7 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Iparomlimab and Tuvonralimab (QL1706); Aromatase Inhibitor (AI); CDK4/6 inhibitor; Ovarian function suppression
Registered summary
This study will evaluate whether adding QL1706 (iparomlimab and tuvonralimab) to neoadjuvant endocrine therapy improves tumor response in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer who have had a poor response to neoadjuvant chemotherapy. The full summary is on the listing.