48 recruiting, 31 completed, 19 active not recruiting, 12 not yet recruiting. 52 Phase 2, 26 Phase 1, 25 Phase 3, 3 Phase 4, 2 Early Phase 1.
Follow darolutamide: new trials by email Literature Review of darolutamide trials Research Report on darolutamide
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 |
|---|---|---|---|---|---|---|
| Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate Cancer Abiraterone Acetate, Biospecimen Collection, Bone Scan - Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 / Phase 3 | Not yet recruiting | ECOG-ACRIN Cancer Research Group | 432 | 2027-01-06 | 2026-10-01 |
| A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India Darolutamide plus androgen deprivation therapy - Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | Not yet recruiting | Bayer | 60 | 2026-11-30 | 2026-10-20 | |
| Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer. Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy - Prostate Cancer | Phase 4 | Not yet recruiting | University of Chicago | 80 | 2026-11-01 | 2026-01-08 |
| A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer. ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide) - Metastatic Hormone-Sensitive Prostate Cancer | Phase 2 | Not yet recruiting | Anhui Medical University | 40 | 2026-10-01 | 2026-08-31 |
| Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) tinengotinib 10 mg QD plus darolutamide, tinengotinib 10 mg QD (2-week on / 1-week off) plus darolutamide, tinengotinib 10 mg QD plus enzalutamide - Prostate Cancer (CRPC) | Phase 2 | Recruiting | TransThera Sciences (Nanjing), Inc. | 182 | 2026-09-18 | 2026-10-13 |
| Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) Saruparib, Placebo, Enzalutamide - Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | Phase 3 | Recruiting | AstraZeneca | 1330 | 2026-09-15 | 2026-10-15 |
| PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC Stereotactic Body Radiotherapy (SBRT), Darolutamide 600 mg twice daily, Androgen Deprivation Therapy (ADT) - Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | Phase 2 | Not yet recruiting | West China Hospital | 254 | 2026-09-15 | 2026-09-10 |
| Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer Ra223, Darolutamide Oral Tablet, Androgen Deprivation Therapy (ADT) - Metastatic Hormone-Sensitive Prostate Cance | Phase 2 | Not yet recruiting | Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD | 50 | 2026-09-01 | 2026-07-21 |
| 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 |
| A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC) darolutamide plus androgen deprivation therapy, Enzalutamide plus androgen deprivation therapy - Metastatic Castration Sensitive Prostate Cancer (mCSPC) | Active not recruiting | Pfizer | 4700 | 2026-08-19 | 2026-10-06 | |
| A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) Rinzimetostat, Darolutamide, Enzalutamide - Metastatic Castration Resistant Prostate Cancer | Phase 3 | Recruiting | ORIC Pharmaceuticals | 600 | 2026-08-03 | 2026-10-05 |
| Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer. Darolutamide, docetaxel, ADT - Prostate Cancer, Prostate | Phase 2 | Not yet recruiting | RenJi Hospital | 200 | 2026-08-01 | 2026-07-28 |
| An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment Darolutamide, ADT - Non-metastatic Castration-resistant Prostate Cancer | Recruiting | Bayer | 800 | 2026-07-31 | 2026-08-18 | |
| Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction QLC5508 (Investigational Product / Formulation T), QLC5508 (Reference Product / Formulation R), Itraconazole - Refractory or Relapsed Solid Tumors | Phase 1 | Recruiting | Qilu Pharmaceutical Co., Ltd. | 48 | 2026-06-09 | 2026-09-15 |
| Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer Darolutamide, Pembrolizumab, Lupron - Prostate Cancer, High-risk Prostate Cancer | Phase 2 | Recruiting | Icahn School of Medicine at Mount Sinai | 40 | 2026-05-21 | 2026-10-07 |
| AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]), Cabazitaxel, Abiraterone - Metastatic Castration-resistant Prostate Cancer | Phase 3 | Recruiting | AstraZeneca | 670 | 2026-05-04 | 2026-10-19 |
| A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. Darolutamide, ADT - High-risk Localized Prostate Cancer | Phase 2 | Recruiting | Bayer | 250 | 2026-04-27 | 2026-10-13 |
| Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC Darolutamide + ADT Combined with Low-dose Docetaxel - mHSPC | Phase 2 | Recruiting | Yonghong Li | 109 | 2026-04-16 | 2026-08-31 |
| How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany darolutamide plus ADT treatment - Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | Recruiting | Bayer | 500 | 2026-04-14 | 2026-05-29 | |
| Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer Darolutamide, Darolutamide combined with ADT - Prostate Cancer | Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 60 | 2026-04-01 | 2026-03-17 |
Showing 20 of 121. Sign in to see all of them.
Prostatic Neoplasms (74) · Neoplasm Metastasis (7) · Prostatic Neoplasms, Castration-Resistant (4) · Adenocarcinoma (3) · Breast Neoplasms (3) · Bulbo-Spinal Atrophy, X-Linked (3) · Neoplasms (3) · Prostatic Diseases (3) · Genital Diseases, Male (2) · Male Urogenital Diseases (2) · Salivary Gland Neoplasms (2) · Urogenital Neoplasms (2) · Anemia (1) · Blast Crisis (1) · Carcinoma, Intraductal, Noninfiltrating (1)
Bayer (27) · AstraZeneca (5) · UNICANCER (5) · Orion Corporation, Orion Pharma (4) · Canadian Cancer Trials Group (2) · ECOG-ACRIN Cancer Research Group (2) · National Cancer Institute (NCI) (2) · ORIC Pharmaceuticals (2) · Swiss Cancer Institute (2) · AdventHealth (1) · Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD (1) · Alliance Foundation Trials, LLC. (1) · Amgen (1) · Anhui Medical University (1) · Ankara Etlik City Hospital (1)
United States (57) · China (25) · France (23) · Spain (22) · United Kingdom (20) · Australia (18) · Canada (18) · Germany (16) · Italy (16) · Belgium (14) · Brazil (12) · Japan (10) · Sweden (10) · Netherlands (9) · Finland (8)
Karim Fizazi (2) · Michael Ong (2) · Aaron Hansen (1) · Alan L Ho (1) · Alejandro Berlin, MD (1) · Alexandra Sokolova (1) · Alicia K Morgans (1) · Ananya Choudhury, Professor (1) · Arun Azad (1) · Arun Azad, MD (1) · Ashkan Mortezavi, MD, PhD (1) · Ashutosh K Tewari, MD (1)
PMID 24974051, PMID 28753851, PMID 34866168, PMID 35179323, PMID 16000589, PMID 19826044, PMID 21799031, PMID 22771826, PMID 23299278, PMID 25420520, PMID 25708161, PMID 25981621, PMID 25995342, PMID 26858312, PMID 26980827, PMID 27068431, PMID 28753849, PMID 28844372, PMID 29042308, PMID 29384722, PMID 29723398, PMID 29740894, PMID 30763142, PMID 31571095, PMID 31727538, PMID 32203306, PMID 32586393, PMID 32905676, PMID 33554636, PMID 34797506, PMID 35153154, PMID 35317973, PMID 35656777, PMID 36055231, PMID 36087070, PMID 36125208, PMID 36753698, PMID 36795843, PMID 36826464, PMID 37103658, PMID 37222151, PMID 37271630, PMID 37660438, PMID 38394384, PMID 38421252, PMID 38429210, PMID 38824003, PMID 39036382, PMID 39164518, PMID 39279580
2023 (6), 2016 (4), 2017 (3), 2025 (3), 2015 (2), U10CA180820 (2), U10CA180868 (2), 2018 (1), 2019 (1), P30CA068485 (1), P30CA093373 (1), P50CA272390 (1), R01CA286127 (1), R01CA300454 (1), UM1CA186691 (1)