47 completed, 30 recruiting, 27 active not recruiting, 9 terminated. 61 Phase 2, 24 Phase 1, 24 Phase 3, 3 Not applicable, 2 Phase 4.
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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 |
|---|---|---|---|---|---|---|
| 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 |
| A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer fezolinetant, enzalutamide, apalutamide - Prostate Cancer | Phase 1 | Recruiting | Astellas Pharma Global Development, Inc. | 56 | 2026-09-25 | 2026-10-16 |
| 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 | 2026-11-04 |
| Study of Oral MRT-2359 With Apalutamide in Prostate Cancer Oral MRT-2359, Apalutamide - Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer | Phase 2 | Recruiting | Monte Rosa Therapeutics, Inc | 25 | 2026-08-18 | 2026-11-05 |
| Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial. Apalutamide (Erleada™) 60 mg or 240 mg tablets, Docetaxel - Metastatic Hormone-sensitive Prostate Cancer | Phase 3 | Recruiting | Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD | 320 | 2026-06-05 | 2026-06-17 |
| 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 |
| Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial Androgen Therapy, Apalutamide, Docetaxel - Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma | Phase 3 | Recruiting | Alliance for Clinical Trials in Oncology | 1260 | 2025-12-01 | 2026-11-03 |
| Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer Androgen Receptor Pathway Inhibitors (ARPIs) - Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | Completed | Ankara Etlik City Hospital | 230 | 2025-10-22 | 2026-10-08 | |
| Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients Local treatment, Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). - Prostate Cancer Metastatic Disease | Phase 2 | Recruiting | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | 192 | 2025-08-01 | 2026-03-25 |
| A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics Darolutamide, Abiraterone acetate, Enzalutamide - Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer | Recruiting | Bayer | 1400 | 2025-07-22 | 2026-07-07 | |
| A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) Enzalutamide, Apalutamide - Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate | Completed | Pfizer | 1300 | 2025-07-21 | 2025-12-08 | |
| Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response Abiraterone, Enzalutamide, Apalutamide - Prostate Cancer (Adenocarcinoma) | Phase 3 | Recruiting | Canadian Cancer Trials Group | 830 | 2025-05-28 | 2026-07-14 |
| Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer SX-682, Apalutamide - Metastatic Castrate-Resistant Prostate Cancer (mCRPC) | Phase 1 / Phase 2 | Recruiting | Institute of Cancer Research, United Kingdom | 78 | 2025-04-28 | 2026-09-08 |
| 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 |
| PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets - Prostate Cancer, Metastatic Cancer | Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 152 | 2024-12-20 | 2025-03-12 | |
| Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET Apalutamide, Androgen receptor (AR) inhibitor - High Risk Prostate Cancer | Phase 2 | Recruiting | Marco Oderda | 94 | 2024-11-25 | 2025-01-06 |
| Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) 177Lu-PMSA-617, Standard of Care - Prostate Cancer Metastatic | Phase 3 | Recruiting | UNICANCER | 500 | 2024-09-12 | 2024-12-20 |
| PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. Apalutamide, Androgen Deprivation Therapy - Androgen Axis Suppression, Prostatectomy | Phase 3 | Recruiting | M.D. Anderson Cancer Center | 120 | 2024-09-10 | 2026-07-22 |
| 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 Abiraterone, Apalutamide, Biospecimen Collection - Recurrent Castration-Sensitive Prostate Carcinoma, Recurrent Prostate Cancer | Phase 2 | Recruiting | Mayo Clinic | 532 | 2024-06-03 | 2026-07-20 |
| Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study Radical prostatectomy, Prostate irradiation, Surgical metastasectomy - Prostate Cancer Metastatic, Prostate Cancer Metastatic to Bone | Not yet recruiting | Medical University of Vienna | 500 | 2024-05-31 | 2024-05-28 |
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Prostatic Neoplasms (96) · Neoplasm Metastasis (7) · Prostatic Neoplasms, Castration-Resistant (3) · Adenocarcinoma (2) · Genital Diseases, Male (2) · Neoplasms (2) · Prostatic Diseases (2) · Bulbo-Spinal Atrophy, X-Linked (1) · Carcinoma, Small Cell (1) · Depression (1) · Fatigue (1) · Genital Neoplasms, Male (1) · Hematologic Neoplasms (1) · Neoplasms by Site (1) · Patient Preference (1)
Janssen Research & Development, LLC (14) · Aragon Pharmaceuticals, Inc. (12) · M.D. Anderson Cancer Center (8) · Bayer (5) · Dana-Farber Cancer Institute (4) · Pfizer (4) · Janssen Pharmaceutical K.K. (3) · Memorial Sloan Kettering Cancer Center (3) · NRG Oncology (3) · University of Washington (3) · AstraZeneca (2) · Fudan University (2) · H. Lee Moffitt Cancer Center and Research Institute (2) · Jonsson Comprehensive Cancer Center (2) · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (2)
United States (83) · Canada (17) · China (16) · United Kingdom (14) · France (13) · Spain (12) · Australia (11) · Germany (11) · Belgium (10) · Brazil (10) · Italy (10) · Japan (10) · Netherlands (8) · Mexico (7) · Poland (7)
Rahul Aggarwal, MD (3) · Amar Kishan (2) · Jingsong Zhang, MD, PhD (2) · Michael Schweizer (2) · Abhishek Solanki, MD MS (1) · Alexandra Sokolova (1) · Ana Aparicio (1) · Ana Molina, MD (1) · Ananya Choudhury, Professor (1)
PMID 38421243, PMID 32878613, PMID 37951974, PMID 38421252, PMID 39163505, PMID 18309951, PMID 27068431, PMID 27160947, PMID 28633425, PMID 29384722, PMID 29420164, PMID 29606109, PMID 29723398, PMID 29740894, PMID 30213449, PMID 30935383, PMID 31122212, PMID 31150574, PMID 31578173, PMID 31980408, PMID 32356465, PMID 32586393, PMID 33683939, PMID 33754187, PMID 33914595, PMID 34039013, PMID 34600602, PMID 34655838, PMID 34797506, PMID 35091711, PMID 35213039, PMID 35317973, PMID 36000794, PMID 36055231, PMID 36082554, PMID 36209239, PMID 36472728, PMID 37060432, PMID 37071764, PMID 37708629, PMID 38161319, PMID 38261983, PMID 38296736, PMID 38494380, PMID 38796422, PMID 38824003, PMID 38940282, PMID 39036382, PMID 39058790, PMID 39074346
2023 (6), 2017 (4), 2015 (3), 2016 (3), 2018 (3), U10CA180868 (3), P30CA015704 (2), 2014 (1), 2019 (1), 2025 (1), I01CX002277 (1), P30CA023074 (1), P30CA072720 (1), R01CA286127 (1), R01CA300454 (1)