28 completed, 26 recruiting, 9 active not recruiting, 2 withdrawn. 31 Phase 2, 21 Phase 3, 11 Phase 1, 1 Early Phase 1, 1 Phase 4.
Follow relugolix: new trials by email Literature Review of relugolix trials Research Report on relugolix
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy - Prostate Cancer, mHSPC | Phase 3 | Recruiting | University College, London | 1500 | 2026-08-28 | 2026-10-16 |
| Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer Androgen Deprivation Therapy (ADT), Radiotherapy - Prostate Cancer | Phase 2 | Recruiting | NYU Langone Health | 90 | 2026-08-06 | 2026-09-03 |
| Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT Leuprolide, Degarelix, Relugolix - Prostate Cancer, Localized Prostate Carcinoma | Phase 2 | Recruiting | Baptist Health South Florida | 50 | 2026-07-29 | 2026-08-06 |
| Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue, Darolutamide - Metastatic Castration-resistant Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 60 | 2026-03-09 | 2026-03-11 |
| REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients) Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) - Prostate Cancer (Adenocarcinoma) | Phase 2 | Recruiting | National Cancer Institute, Naples | 50 | 2026-02-23 | 2026-07-21 |
| Insights in Endocervical Mucus Secretion Gonadotropin Releasing Hormone Antagonists Relugolix - Cervical Mucus | Phase 4 | Recruiting | Oregon Health and Science University | 15 | 2026-01-02 | 2026-01-08 |
| Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI - Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | Phase 2 | Recruiting | University of Utah | 160 | 2025-10-27 | 2026-06-23 |
| Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial Biospecimen Collection, Computed Tomography, Flotufolastat F-18 Gallium - Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8 | Phase 2 | Recruiting | Mayo Clinic | 30 | 2025-08-25 | 2026-09-23 |
| The COSMYC Trial (COmbined Suppression of MYC) ZEN-3694, Testosterone cypionate, Enzalutamide - Metastatic Castration-resistant Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 50 | 2025-08-19 | 2026-06-18 |
| Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study Relugolix/estradiol/norethisterone acetate - Uterine Bleeding, Uterine Leiomyomas | Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 111 | 2025-05-02 | 2025-08-17 | |
| MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy Relugolix + Estradiol + Norethindrone Acetate - Pregnancy Related, Pregnancy Complications | Active not recruiting | Sumitomo Pharma Switzerland GmbH | 530 | 2025-04-30 | 2025-08-01 | |
| Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer Gonadotropin Releasing Hormone Agonists and Antagonists, Bicalutamide, Biopsy Procedure - High Risk Prostate Carcinoma, Localized Prostate Adenocarcinoma | Phase 2 | Withdrawn | OHSU Knight Cancer Institute | 2025-04-16 | 2025-09-23 | |
| REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial Abiraterone Acetate, Bicalutamide, Biospecimen Collection - Recurrent Prostate Carcinoma, Stage III Prostate Cancer AJCC v8 | Phase 3 | Recruiting | Emory University | 72 | 2025-01-31 | 2026-02-24 |
| Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI), Docetaxel - Metastatic Castration Sensitive Prostate Cancer | Phase 2 | Active not recruiting | H. Lee Moffitt Cancer Center and Research Institute | 25 | 2025-01-10 | 2026-04-01 |
| Relugolix + Enzalutamide Study in High-Risk Prostate Cancer Relugolix and Enzalutamide - Androgen Deprivation Therapy, Locally Advanced Prostate Cancer | Phase 1 | Recruiting | University of Oklahoma | 46 | 2024-12-26 | 2026-03-05 |
| Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) Darolutamide, Relugolix - Prostate Cancer, Advanced Prostate Cancer | Phase 2 | Active not recruiting | Atish Choudhury, MD | 33 | 2024-12-13 | 2026-03-09 |
| The University of Miami Adapt (UAdapt) Trial FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix, HypoLEAD - Prostate Cancer | Phase 2 | Recruiting | University of Miami | 130 | 2024-11-06 | 2026-02-18 |
| Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer Darolutamide, Relugolix, Radical Prostatectomy - Prostate CA, Prostate Cancer (Adenocarcinoma) | Phase 1 | Recruiting | AdventHealth | 30 | 2024-10-22 | 2026-02-05 |
| Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial Biopsy, Biospecimen Collection, Computed Tomography - Prostate Adenocarcinoma | Phase 2 | Recruiting | Sean Sachdev | 50 | 2024-09-06 | 2026-06-05 |
| The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate - Endometriosis | Phase 3 | Recruiting | Main Line Health | 110 | 2024-08-15 | 2026-06-12 |
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Prostatic Neoplasms (36) · Leiomyoma (12) · Endometriosis (11) · Menorrhagia (5) · Dysmenorrhea (3) · Myofibroma (3) · Pain (3) · Adenocarcinoma (2) · Neoplasm Metastasis (2) · Pelvic Pain (2) · Pregnancy Complications (2) · Dyspareunia (1) · Eunuchism (1) · Hypogonadism (1) · Myoma (1)
Myovant Sciences GmbH (10) · Takeda (8) · Millennium Pharmaceuticals, Inc. (3) · NRG Oncology (3) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (3) · Sumitomo Pharma America, Inc. (3) · Sumitomo Pharma Switzerland GmbH (3) · Emory University (2) · H. Lee Moffitt Cancer Center and Research Institute (2) · Mayo Clinic (2) · NYU Langone Health (2) · ASKA Pharmaceutical Co., Ltd. (1) · AdventHealth (1) · Atish Choudhury, MD (1) · Baptist Health South Florida (1)
United States (52) · Japan (9) · Italy (8) · Poland (8) · Brazil (7) · Canada (7) · Czechia (6) · South Africa (6) · Belgium (5) · Chile (5) · Hungary (5) · United Kingdom (5) · Australia (3) · Finland (3) · New Zealand (3)
Jingsong Zhang, MD, PhD (2) · Sagar A Patel, MD (2) · Samuel Denmeade, MD (2) · Abhishek Solanki, MD MS (1) · Alicia Morgans, MD (1) · Ananya Choudhury, Professor (1) · Arthur Hung (1) · Atish Choudhury, MD, PhD (1) · Benjamin Spieler, MD (1) · Bridget F Koontz (1)
PMID 36357960, PMID 33596357, PMID 37477173, PMID 37863160, PMID 35415708, PMID 35675604, PMID 35717987, PMID 37183454, PMID 37283994, PMID 37666383, PMID 37982388, PMID 39466126, PMID 16508866, PMID 25652685, PMID 28084714, PMID 30741797, PMID 31069056, PMID 31429205, PMID 31594635, PMID 32912633, PMID 34154590, PMID 34711224, PMID 34895700, PMID 35587650, PMID 36472728, PMID 37060432, PMID 37365436, PMID 37713020, PMID 38243752, PMID 38421243, PMID 38488039, PMID 38906210, PMID 39084498, PMID 39088398, PMID 40180682, PMID 40320117, PMID 41174189, PMID 41706486, PMID 42031503, PMID 42117295, PMID 42656189
2017 (5), U10CA180868 (3), 2016 (2), P30CA138292 (2), 2014 (1), 2018 (1), I01CX002277 (1), P30CA060553 (1), P30CA168524 (1), P50CA272391 (1), R01CA286127 (1), R01CA300454 (1), R01HD115770 (1), U10CA180820 (1)