Clinical Trials for Prostate Cancer

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma on ongoing ADT (ECOG 0–1) who have progressed after 1–2 prior androgen receptor pathway inhibitors and are chemotherapy-naïve for prostate cancer are randomized to docetaxel (with prednisone) versus docetaxel plus pasritamig, an IV KLK2×CD3 bispecific T-cell–redirecting antibody designed to induce T-cell–mediated killing of KLK2-expressing prostate cancer cells. Treatment continues until confirmed radiographic progression or other protocol-defined discontinuation criteria.

ClinicalTrials.gov ID: NCT07225946

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Randomized open-label trial for men with progressive mCRPC, ECOG 0–1, after 1–2 androgen receptor pathway inhibitors and no prior taxane/cytotoxic chemotherapy for mCRPC. Patients receive BNT324/DB-1311, a B7-H3–targeted antibody-drug conjugate carrying a topoisomerase I inhibitor payload, versus standard docetaxel plus prednisone/prednisolone while continuing castration therapy.

ClinicalTrials.gov ID: NCT07365995

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with PSMA-PET–positive progressive mCRPC previously treated with an androgen-receptor pathway inhibitor, taxane chemotherapy, and 2–6 cycles of a PSMA-directed beta-emitting radioconjugate are randomized to AZD2265, a PSMA-targeted actinium-225 alpha radioligand, or investigator’s choice of cabazitaxel, an androgen-receptor pathway inhibitor switch, or radium-223.

ClinicalTrials.gov ID: NCT07611110

Phase II Study of Zanzalintinib in Men With Aggressive Variant Prostate Cancer (NAPOLEON Study)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Men with aggressive-variant metastatic castration-resistant prostate cancer progressing during or after at least one second-generation androgen receptor pathway inhibitor receive oral zanzalintinib 60 mg daily while continuing castration. Zanzalintinib is an investigational multikinase inhibitor targeting VEGFR2, MET, and the TAM-family kinases TYRO3, AXL, and MER.

ClinicalTrials.gov ID: NCT07218666

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: PSMA PET–positive metastatic castration‑resistant prostate cancer on continuous ADT after ≥1 ARSI; no PSMA‑negative lesions, with Part 3 requiring prior Lu‑177–PSMA (and allowing ≤1 prior taxane). Investigational therapy is Ac‑225 rosopatamab tetraxetan (225Ac‑J591), a PSMA‑targeted alpha‑emitting monoclonal antibody delivered in a single fractionated cycle (Day 1/15) at 45–60 kBq/kg, with randomized dose optimization in PSMA‑RT–naive patients and dose escalation/expansion in those post‑Lu‑177.

ClinicalTrials.gov ID: NCT06549465

A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Men with metastatic castration-resistant prostate cancer progressing on abiraterone (ECOG 0–1, on continuous ADT, no prior second‑generation AR inhibitor or mCRPC chemotherapy) are randomized to enzalutamide alone versus enzalutamide plus ZEN003694, an oral pan-BET bromodomain inhibitor (BRD2/3/4/BRDT) aiming to suppress AR/MYC-driven transcription. Two predefined cohorts (poor vs good prior abiraterone responders) are included; crossover from control at radiographic progression is allowed.

ClinicalTrials.gov ID: NCT04986423

Phase II Single Arm Study Testing SBRT, Adenosine Signaling Modulation (AB680, AB928), and Immune Checkpoint Inhibition (AB122) for Men With Hormone Sensitive Oligometastatic Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Men with hormone-sensitive oligometastatic prostate adenocarcinoma (1–3 SBRT-amenable lesions; prior definitive therapy; testosterone >125 ng/dL; PSA 0.5–50; PSADT <15 months; ECOG 0–2) receive metastasis-directed SBRT plus adenosine-axis modulation with quemliclustat (CD73 inhibitor) and etrumadenant (A2A/A2B receptor antagonist) followed by PD-1 blockade with zimberelimab. Aims to improve biochemical and radiographic control versus historical SBRT alone while deferring ADT.

ClinicalTrials.gov ID: NCT05915442

A Phase 2a Multicenter, Dose-Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Men with metastatic castration-resistant prostate adenocarcinoma after at least one second-generation AR inhibitor (± prior taxane), castrate and ECOG 0–2, with a lesion accessible for transperineal intratumoral access/biopsy, and without visceral or brain metastases. Treatment involves partial oncolysis of a target lesion followed by intratumoral SV-102, a fixed-dose multi-agent immunotherapy (anti-CTLA-4, anti-PD-1, CD40 agonist, TLR9 agonist) designed to induce in situ vaccination; dose is escalated/optimized across cohorts.

ClinicalTrials.gov ID: NCT06533644

A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: mCRPC patients with adenocarcinoma after exactly one prior second‑generation ARSI and no taxane in the mCRPC setting receive the CD46‑targeted antibody‑drug conjugate FG‑3246 (FOR46), an MMAE‑conjugated monoclonal antibody, given IV every 3 weeks at randomized doses (1.8, 2.4, or 2.7 mg/kg). Requires recent CRPC‑era tissue, measurable/evaluable disease, and excludes prior CD46 therapy, neuroendocrine histology, >1 ARSI, significant neuropathy, or recent systemic therapy.

ClinicalTrials.gov ID: NCT06842498