Clinical Trials for Prostate Cancer

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve 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: Chemotherapy-naïve mCRPC adults (ECOG 0–1) who progressed on exactly one prior AR pathway inhibitor (enzalutamide, apalutamide, or darolutamide) and remain on castration are randomized to xaluritamig plus abiraterone versus investigator’s choice of abiraterone, docetaxel, or cabazitaxel. Xaluritamig (AMG 509) is a STEAP1×CD3 bispecific T‑cell engager designed to redirect T‑cell cytotoxicity; exclusions include prior abiraterone progression, prior STEAP1 therapy, mCRPC chemo, significant prior radionuclide/PSMA therapy, and neuroendocrine histology.

ClinicalTrials.gov ID: NCT07213674

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

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 mCRPC who have progressed on at least one next‑generation hormonal agent and 1–2 taxane regimens (ECOG 0–1) are randomized to the CYP11A1 inhibitor opevesostat (with physiologic steroid replacement) versus switching to abiraterone/prednisone or enzalutamide; efficacy will be evaluated separately in AR ligand‑binding domain mutation–positive and –negative cohorts. Prior PARP inhibitor or 177Lu‑PSMA‑617 is allowed; key exclusions include significant cardiovascular, thromboembolic, seizure, or endocrine risks and drug–drug interactions.

ClinicalTrials.gov ID: NCT06136624

MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

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 (ECOG 0–1) with radiographic/clinical progression on ongoing ADT after exactly one prior next-generation hormonal agent (abiraterone or enzalutamide), with prior PARP inhibitor use or ineligibility/refusal and no prior taxane for mCRPC (docetaxel allowed only in hormone-sensitive setting), are randomized to opevesostat (oral CYP11A1 steroidogenesis inhibitor) plus mandated physiologic glucocorticoid/mineralocorticoid replacement vs switching to the alternative NHA (abiraterone/prednisone or enzalutamide), with outcomes assessed in both AR-LBD mutation–positive and –negative disease.

ClinicalTrials.gov ID: NCT06136650

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

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 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

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 II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

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.

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: Adults with advanced/metastatic solid tumors (endometrial, gastric, mCRPC, ovarian, colorectal, urothelial, biliary) receive datopotamab deruxtecan (anti‑TROP2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with agents such as capecitabine/5‑FU, bevacizumab ± platinum, prednisone (mCRPC), platinum in urothelial cancer, or bispecific PD‑1/CTLA‑4 (volrustomig) or PD‑1/TIGIT (rilvegostomig) immunotherapies. Key exclusions include active/untreated CNS disease, prior TROP2- or deruxtecan-based ADCs, significant ILD/pneumonitis history, and uncontrolled infections/comorbidities.

ClinicalTrials.gov ID: NCT05489211

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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 cancer that has radiographic/PSA progression on abiraterone or enzalutamide (with ongoing ADT) receive tinengotinib combined with their current ARSI (abiraterone/prednisone or enzalutamide). Tinengotinib is an oral spectrum-selective multikinase inhibitor (targets Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, CSF1R) aiming to enhance antitumor activity in this post-ARSI setting.

ClinicalTrials.gov ID: NCT06457919