High-risk Prostate Cancer Clinical Trials

13 recruitingLast updated: June 17, 2026

There are 13 actively recruiting high-risk prostate cancer clinical trials across 5 countries. Studies span Phase 2, Not Applicable, Phase 1, Early Phase 1. Top locations include Bologna, Italy, Italy, Boston, Massachusetts, United States, Charleston, South Carolina, United States. Updated daily from ClinicalTrials.gov.


High-risk Prostate Cancer Trials at a Glance

13 actively recruiting trials for high-risk prostate cancer are listed on ClinicalTrialsFinder across 6 cities in 5 countries. The largest study group is Phase 2 with 7 trials, with the heaviest enrollment activity in Bologna, Boston, and Charleston. Lead sponsors running high-risk prostate cancer studies include Center Eugene Marquis, Edwin Posadas, MD, and Cellvax Therapeutics Inc.

Browse high-risk prostate cancer trials by phase

Treatments under study

About High-risk Prostate Cancer Clinical Trials

Looking for clinical trials for High-risk Prostate Cancer? There are currently 13 studies actively recruiting participants. Clinical trials offer access to new treatments before they are widely available, and every approved therapy in use today was first tested through a clinical trial.

Below you can browse trials, sign up for alerts when new High-risk Prostate Cancer trials open, and view eligibility criteria for each study. Each listing includes the study phase, locations, and enrollment details.

Frequently Asked Questions

Common questions about High-risk Prostate Cancer clinical trials

A clinical trial is a carefully designed research study that tests new medical treatments, drugs, devices, or approaches in human volunteers. Every approved medication and treatment available today was proven safe and effective through clinical trials.

All clinical trials are reviewed and approved by Institutional Review Boards (IRBs) — independent committees that evaluate patient safety. Trials follow strict protocols, and your health is monitored closely throughout. You can withdraw at any time.

Not necessarily. Many trials compare the new treatment against the current standard of care, meaning all participants receive active treatment. When placebos are used, they are typically combined with standard treatment, not given alone. The trial description will always specify the design.

Under the Affordable Care Act, most private insurers are required to cover routine patient care costs during a clinical trial. The sponsor typically covers the investigational treatment itself. Medicare also covers routine costs for qualifying trials.

Yes. Participation is completely voluntary. You can withdraw at any time, for any reason, without it affecting your access to standard medical care.

Each trial has specific eligibility criteria — including age, diagnosis, disease stage, prior treatments, and general health. Browse the trials listed above and check their eligibility sections. You can also contact the trial site directly to discuss your situation.

Showing 113 of 13 trials

Recruiting
Phase 2

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

Prostate CancerHigh-risk Prostate Cancer
Icahn School of Medicine at Mount Sinai40 enrolled1 locationNCT07027124
Recruiting
Phase 2

Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Prostate CancerHigh-risk Prostate CancerIntermediate Risk Prostate Cancer
Martin T. King, MD, PhD23 enrolled4 locationsNCT07393867
Recruiting
Not Applicable

Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer

High-risk Prostate Cancer
Center Eugene Marquis390 enrolled1 locationNCT07189598
Recruiting

Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer

Treatment ResponseHigh-risk Prostate CancerPSMA PET+1 more
Xijing Hospital110 enrolled9 locationsNCT07553780
Recruiting
Phase 1

Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617

Prostate CancerLocalized Prostate CarcinomaHigh-risk Prostate Cancer+2 more
Thomas Hope45 enrolled1 locationNCT07054346
Recruiting
Phase 2

A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss

High-risk Prostate Cancer
VA Office of Research and Development30 enrolled6 locationsNCT05593497
Recruiting
Early Phase 1

A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

High-risk Prostate Cancer
Edwin Posadas, MD20 enrolled1 locationNCT06888102
Recruiting
Not Applicable

Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.

High-risk Prostate Cancer
IRCCS Azienda Ospedaliero-Universitaria di Bologna244 enrolled1 locationNCT07357259
Recruiting
Phase 1Phase 2

Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.

High-risk Prostate Cancer
Rabin Medical Center20 enrolled1 locationNCT07208240
Recruiting

PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Deprivation Therapy for Organ-confined High-risk Prostate Cancer: the PROSTAR Trial

High-risk Prostate Cancer
Istituto Clinico Humanitas49 enrolled3 locationsNCT06949254
Recruiting
Phase 2

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

High-risk Prostate Cancer
Marco Oderda94 enrolled1 locationNCT06758882
Recruiting
Phase 2

FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer

Prostate CancerProstate CancersProstate Cancer (Adenocarcinoma)+4 more
Cellvax Therapeutics Inc100 enrolled3 locationsNCT06636682
Recruiting
Phase 2

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Neoadjuvant TherapyHigh-risk Prostate CancerLocally Advanced Prostate Cancer+1 more
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School900 enrolled1 locationNCT05406999