Clinical Trials for Prostate Cancer

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

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 de novo, high-volume metastatic hormone-sensitive prostate adenocarcinoma on ADT (with or without recent darolutamide or abiraterone) and no prior docetaxel are treated with xaluritamig plus either darolutamide or abiraterone. Xaluritamig (AMG 509) is an investigational STEAP1×CD3 bispecific T‑cell engager; the study assesses safety and preliminary activity of these combinations.

ClinicalTrials.gov ID: NCT07140900

A Phase Ib Clinical Trial to Optimize Risk Benefit of REGN5678 (PSMAxCD28 Bispecific Antibody) Plus Cemiplimab (Anti-PD-1 Monoclonal Antibody) in Patients With Metastatic Castration-resistant Prostate Cancer

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 cancer progressing after ≥2 prior systemic regimens (including a next‑generation AR pathway inhibitor), ECOG 0–1, and adequate organ function; prior PSMA‑targeted therapy and immunotherapy allowed. Treatment is REGN5678 (nezastomig), a PSMA×CD28 T‑cell costimulatory bispecific antibody with a weekly lead‑in then q3w dosing, combined q3w with the PD‑1 inhibitor cemiplimab.

ClinicalTrials.gov ID: NCT06826768

MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

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 metastatic castration-resistant prostate adenocarcinoma (taxane-naive in the mCRPC setting) after 1–2 AR pathway inhibitors are randomized to ifinatamab deruxtecan (I-DXd, a B7-H3–targeting antibody–drug conjugate delivering a topoisomerase I inhibitor) alone or combined with MK-5684 (opevesostat, a CYP11A1 inhibitor suppressing steroidogenesis) or an ARPI (abiraterone or enzalutamide) versus docetaxel. Key exclusions include prior ILD/pneumonitis and prior taxane for mCRPC; endpoints include safety, PSA50, and radiographic efficacy.

ClinicalTrials.gov ID: NCT06863272

A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Black or African American men with locally advanced/high-risk, biochemically recurrent, or metastatic prostate cancer receive standard therapies first in clinic then at home with remote monitoring to compare safety and patient-centered outcomes. Eligible regimens for home administration include ADT (leuprolide, degarelix), cabazitaxel, pembrolizumab, and bone-modifying agents (zoledronic acid, denosumab); oral agents like second-generation antiandrogens or PARP inhibitors may be continued but oral-only regimens are excluded.

ClinicalTrials.gov ID: NCT07073794

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

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: Enrolls adults (ECOG 0–1) with unresectable/metastatic colorectal adenocarcinoma or metastatic castration-resistant prostate cancer. Tests the B7-H3–targeted antibody-drug conjugate GSK5764227 (anti–B7-H3 mAb linked to a topoisomerase inhibitor payload) in combination with bevacizumab ± 5-FU/leucovorin for metastatic CRC, or with enzalutamide for mCRPC.

ClinicalTrials.gov ID: NCT07277270

A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer

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: Enrolling adults with metastatic castration-resistant prostate adenocarcinoma with bone and/or nodal metastases and no clear visceral metastases (on ongoing castration; PSA ≥2 ng/mL; ECOG 0–1). Participants receive IV pasritamig (JNJ-78278343), a KLK2×CD3 bispecific T-cell–redirecting antibody to drive T-cell–mediated tumor lysis, in combination with JNJ-86974680, an adenosine A2A receptor antagonist intended to relieve adenosine-mediated T-cell immunosuppression.

ClinicalTrials.gov ID: NCT07319871

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

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: For adult men with metastatic castration-resistant prostate adenocarcinoma (including neuroendocrine differentiation but not pure small cell) progressing on ongoing androgen deprivation therapy and previously treated with at least one androgen receptor pathway inhibitor (ECOG 0–1, PSA ≥2). Patients receive oral valemetostat (investigational dual EZH1/EZH2/PRC2 inhibitor that reduces H3K27me3 to reverse transcriptional repression) in combination with oral darolutamide, with continued background ADT, in dose-escalation/expansion to assess safety and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT07244341

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

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: For men with de novo or recurrent metastatic hormone-sensitive prostate cancer on ongoing ADT (castrate testosterone; ECOG 0–2), including those with limited prior taxane and ≤6 months prior ARPI exposure (no ongoing darolutamide) and at least one metastatic lesion. Evaluates adding tulmimetostat (DZR123), an oral dual EZH1/EZH2 (PRC2) inhibitor, to darolutamide (and in dose-escalation also with abiraterone/prednisone) versus darolutamide alone while continuing ADT.

ClinicalTrials.gov ID: NCT07190300

Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer

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 prostate adenocarcinoma post-prostatectomy (± prior adjuvant/salvage RT ≥3 months) who have biochemical recurrence with non-castrate testosterone and oligometastatic disease (<3 lesions on conventional imaging and PSMA PET/CT; ECOG 0–1) receive intradermal pTVG-HP/MVI-816, a plasmid DNA vaccine encoding prostatic acid phosphatase (PAP) to elicit PAP-specific T-cell responses, combined with nivolumab (PD-1 blockade). Lesions deemed treatment-resistant during therapy are ablated with targeted radiation.

ClinicalTrials.gov ID: NCT07090148

A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)

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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Single-arm study enrolling adults with advanced/metastatic prostate, breast, pancreatic, or NSCLC progressing after standard systemic therapy who are on opioids and can briefly defer next-line cancer treatment. Participants receive daily oral axelopran monotherapy, an investigational peripherally acting μ-opioid receptor antagonist intended to block GI opioid effects, with response assessed at about 6 weeks.

ClinicalTrials.gov ID: NCT07354919