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Showing 1–24 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Clear all
Active, not recruiting Phase 2 Interventional

A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

NCT05059236
View directory record Official record
Conditions
Metastatic Hormone-sensitive Prostate Cancer
Interventions
Darolutamide (BAY1841788, Nubeqa), ADT
Drug · Other
Lead sponsor
Bayer
Industry
Eligibility
18 Years and older · Male only
Enrollment
223 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
31
States / cities
Homewood, Alabama • Tucson, Arizona • Los Angeles, California + 24 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 3 Interventional Results available

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

NCT02489318
View directory record Official record
Conditions
Prostate Cancer
Interventions
Apalutamide, Placebo, Androgen Deprivation Therapy (ADT)
Drug
Lead sponsor
Aragon Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older · Male only
Enrollment
1,052 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2027
U.S. locations
39
States / cities
Homewood, Alabama • Tucson, Arizona • San Bernardino, California + 36 more
Source: ClinicalTrials.gov public record
Updated Jul 5, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Completed Phase 2 Interventional Results available

The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

NCT03899467
View directory record Official record
Conditions
Metastatic Castrate Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions
GT0918
Drug
Lead sponsor
Suzhou Kintor Pharmaceutical Inc,
Industry
Eligibility
18 Years and older · Male only
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
10
States / cities
Athens, Georgia • Louisville, Kentucky • Towson, Maryland + 7 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2024 · Synced Jul 21, 2026, 11:15 AM EDT
Recruiting No phase listed Observational

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

NCT07406282
View directory record Official record
Conditions
Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
Interventions
Darolutamide, Abiraterone acetate, Enzalutamide, Apalutamide
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years and older · Male only
Enrollment
1,400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Completed No phase listed Observational Results available

A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces

NCT06151418
View directory record Official record
Conditions
Prostatic Neoplasms
Interventions
Novel hormonal therapy
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older · Male only
Enrollment
2,313 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 3, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

NCT04191096
View directory record Official record
Conditions
Metastatic Hormone-Sensitive Prostate Cancer
Interventions
Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT), Placebo
Biological · Drug · Other
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older · Male only
Enrollment
1,251 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
27
States / cities
Anchorage, Alaska • Duarte, California • Los Angeles, California + 22 more
Source: ClinicalTrials.gov public record
Updated Apr 28, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Not yet recruiting Phase 2 Interventional

Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial

NCT07650240
View directory record Official record
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
Interventions
Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate, Lutetium Lu 177 Vipivotide Tetraxetan, Prednisone, PSMA PET-CT Scan, Quality-of-Life Assessment, Single Photon Emission Computed Tomography
Drug · Procedure · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Male only
Enrollment
202 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Jun 16, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Recruiting Phase 2 Interventional

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

NCT06991556
View directory record Official record
Conditions
Metastatic Hormone-sensitive Prostate Cancer
Interventions
JSB462, Abiraterone, Enzalutamide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Male only
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2035
U.S. locations
21
States / cities
La Jolla, California • Santa Monica, California • Denver, Colorado + 18 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 4 Interventional

PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer

NCT06479187
View directory record Official record
Conditions
Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions
18F-rhPSMA-7.3, PET/CT
Drug · Device
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years and older · Male only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Nov 4, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Completed Phase 2 Interventional

Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

NCT06312670
View directory record Official record
Conditions
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Prostate Cancer, Prostate Adenocarcinoma
Interventions
EPI-7386, Enzalutamide, Androgen Deprivation Therapy (ADT)
Drug
Lead sponsor
Pedro Barata, MD, MSc
Other
Eligibility
19 Years and older · Male only
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
2
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated May 28, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 3 Interventional

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT04720157
View directory record Official record
Conditions
Prostatic Neoplasms
Interventions
177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
1,140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
70
States / cities
Scottsdale, Arizona • La Jolla, California • Los Angeles, California + 50 more
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

NCT04126070
View directory record Official record
Conditions
Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma
Interventions
Androgen Deprivation Therapy, Nivolumab, Docetaxel
Drug
Lead sponsor
Xiao X. Wei, MD
Other
Eligibility
18 Years and older · Male only
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
6
States / cities
La Jolla, California • Tampa, Florida • Baltimore, Maryland + 2 more
Source: ClinicalTrials.gov public record
Updated May 26, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 2 Interventional

REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer

NCT03951831
View directory record Official record
Conditions
Prostate Cancer Metastatic
Interventions
REGN2810, Degarelix, Leuprolide Acetate, Docetaxel
Drug
Lead sponsor
Mark Stein
Other
Eligibility
18 Years to 99 Years · Male only
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2028
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 24, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Withdrawn Phase 1Phase 2 Interventional

Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

NCT03343977
View directory record Official record
Conditions
Metastatic Hormone-Sensitive Prostate Cancer
Interventions
docetaxel 50mg/m2, docetaxel 75mg/m2
Drug
Lead sponsor
Peng Wang, MD PhD
Other
Eligibility
18 Years and older · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2029
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Jul 16, 2018 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Early Phase 1 Interventional

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

NCT05683964
View directory record Official record
Conditions
Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Drug · Diagnostic Test
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
40 Years and older · Male only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 12, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Not yet recruiting Phase 2 Interventional

RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

NCT07645326
View directory record Official record
Conditions
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions
Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitor (ARPI), Prostate Radiation, Docetaxel
Drug · Radiation
Lead sponsor
Georgetown University
Other
Eligibility
18 Years and older · Male only
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2032
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Jun 16, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 3 Interventional Results available

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

NCT05288166
View directory record Official record
Conditions
Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Abiraterone Acetate, Steroid Synthesis Inhibitors, Cytochrome P-450, Enzyme Inhibitors, Prednisone, Prednisolone, Cyclin-Dependent Kinase 4, Cyclin-Dependent Kinase 6
Interventions
Abemaciclib, Abiraterone, Prednisone or Prednisolone, Placebo for Abemaciclib
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older · Male only
Enrollment
925 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
63
States / cities
Prescott, Arizona • Prescott Valley, Arizona • Tucson, Arizona + 57 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Recruiting Phase 1Phase 2 Interventional

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

NCT07190300
View directory record Official record
Conditions
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions
Tulmimetostat, Darolutamide, Abiraterone
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Male only
Enrollment
181 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2032
U.S. locations
8
States / cities
Birmingham, Alabama • Iowa City, Iowa • Westwood, Kansas + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Completed Phase 3 Interventional Results available

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT02677896
View directory record Official record
Conditions
Metastatic Hormone Sensitive Prostate Cancer
Interventions
Enzalutamide, Placebo
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older · Male only
Enrollment
1,150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2024
U.S. locations
34
States / cities
Homewood, Alabama • Anchorage, Alaska • Tucson, Arizona + 30 more
Source: ClinicalTrials.gov public record
Updated Oct 23, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Recruiting Phase 2 Interventional

Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

NCT07216248
View directory record Official record
Conditions
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions
relugolix + ARPI., Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI
Drug
Lead sponsor
University of Utah
Other
Eligibility
18 Years and older · Male only
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Completed No phase listed Observational Results available

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

NCT06072196
View directory record Official record
Conditions
Prostatic Neoplasms
Interventions
Novel hormonal therapy
Drug
Lead sponsor
Pfizer
Industry
Eligibility
65 Years and older · Male only
Enrollment
3,017 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Dec 30, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Recruiting Phase 1 Interventional

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

NCT07140900
View directory record Official record
Conditions
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions
Xaluritamig, Darolutamide, Abiraterone
Drug
Lead sponsor
Amgen
Industry
Eligibility
18 Years and older · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
8
States / cities
San Francisco, California • Boston, Massachusetts • Minneapolis, Minnesota + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2026 · Synced Jul 21, 2026, 11:15 AM EDT
Completed No phase listed Observational

A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)

NCT07086651
View directory record Official record
Conditions
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms, Prostate Cancer
Interventions
Enzalutamide, Apalutamide
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older · Male only
Enrollment
1,300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Dec 7, 2025 · Synced Jul 21, 2026, 11:15 AM EDT
Active, not recruiting Phase 2 Interventional

Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)

NCT05241860
View directory record Official record
Conditions
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
Interventions
Pharmacotherapy Discontinuation, Follow-Up, Questionnaire Administration, Quality-of-Life Assessment
Other
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older · Male only
Enrollment
79 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2033
U.S. locations
326
States / cities
Phoenix, Arizona • Fort Smith, Arkansas • Little Rock, Arkansas + 234 more
Source: ClinicalTrials.gov public record
Updated Dec 21, 2025 · Synced Jul 21, 2026, 11:15 AM EDT