Clinical Trials for Prostate Cancer

A Phase II Multicenter Trial of ESK981 in Patients With Select 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.

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: Adults with ECOG 0–2 and measurable disease in three cohorts: refractory pancreatic adenocarcinoma/adenosquamous carcinoma; high-grade (Ki-67 >20%) pancreatic or GI neuroendocrine neoplasms post–≥1 line; or metastatic neuroendocrine prostate carcinoma after ≥1 line, receive oral ESK981 monotherapy (5 days on/2 off). ESK981 is a multitarget TKI with anti-angiogenic activity (VEGFR1/2/3, TIE-2) and PIKfyve inhibition (autophagy/immune modulation).

ClinicalTrials.gov ID: NCT05988918

A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With 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: Men with metastatic castration-resistant prostate cancer, castrate testosterone, and radiographic progression (first-line mCRPC candidates for enzalutamide or after one prior AR pathway agent) receive enzalutamide plus the investigational fatty acid synthase (FASN) inhibitor TVB-2640 (denifanstat) with dose escalation. Key exclusions include untreated/active brain mets, seizure history, significant ocular surface disease, and problematic CYP/P-gp drug interactions.

ClinicalTrials.gov ID: NCT05743621

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic 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: Enrolls adults with metastatic prostate adenocarcinoma (mainly mCRPC after prior ARPI ± docetaxel; one cohort includes mHSPC with non-castrate testosterone and bone-only disease) to receive the KLK2×CD3 bispecific T‑cell engager pasritamig (JNJ‑78278343) combined with either cetrelimab (PD‑1 inhibitor), a taxane (docetaxel or cabazitaxel), or an ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone/prednisone). Open-label cohorts assess safety and preliminary activity to define recommended regimens; ECOG 0–1 and measurable/evaluable disease required.

ClinicalTrials.gov ID: NCT05818683

A Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, &Amp; Avelumab in Advanced Metastatic Castrate-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.

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 progressive mCRPC with bone-predominant disease (no visceral metastases), previously treated with AR-targeted therapy and/or taxane, are randomized to radium-223 alone versus radium-223 plus peposertib (M3814; oral DNA-PK inhibitor) versus radium-223 plus peposertib plus avelumab (anti–PD-L1). Key exclusions include active autoimmune disease requiring immunosuppression and concurrent abiraterone with radium-223; ECOG 0–1 (phase I) or 0–2 (phase II) required.

ClinicalTrials.gov ID: NCT04071236

Dynamic Investigator Initiated Enterprise (DIVINE) in 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.

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: Adults with metachronous recurrent oligometastatic hormone-sensitive prostate cancer (≤5 mets, ≥1 extra-pelvic) are randomized to SBRT alone versus SBRT plus 6 months of ADT and an androgen receptor pathway inhibitor (abiraterone/prednisone, apalutamide, darolutamide, or enzalutamide), then observation. ADT options include LHRH agonists/antagonists or an investigational long-acting GnRH antagonist depot (Debio 4228/degarelix), with the trial assessing whether short-course systemic intensification improves modified radiographic PFS.

ClinicalTrials.gov ID: NCT06378866

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced 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 metastatic castration‑resistant prostate adenocarcinoma (PCWG3; measurable/evaluable disease, PSA ≥2, on castration, ECOG 0–1; excludes active autoimmune disease requiring immunosuppression and recent major CV/CNS events) receive combination immunotherapy with pasritamig (KLK2×CD3 T‑cell–redirecting bispecific) plus JNJ‑87189401 (PSMA×CD28 costimulatory bispecific) to evaluate safety and preliminary activity. Suitable for mCRPC including those with small cell/neuroendocrine features (but not pure small cell/large cell NE).

ClinicalTrials.gov ID: NCT06095089

Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy

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: Men with PSMA PET–positive biochemical recurrence after definitive local therapy, no visceral/bone mets, testosterone >100 ng/dL, and PSA DT <12 months are randomized to short-course enzalutamide without ADT versus enzalutamide plus PDS01ADC (NHS-IL12), an IL‑12 immunocytokine that targets exposed histones in necrotic tumor regions to deliver IL‑12 and stimulate NK/T‑cell activity. Designed to test whether adding PDS01ADC prolongs PSA control; retreatment with enzalutamide alone allowed upon PSA return to baseline.

ClinicalTrials.gov ID: NCT06096870

A Phase 1b/2a, MultiCenter, Open- Label Study of Pocenbrodib as Monotherapy or in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With 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: Men with imaging-confirmed mCRPC who have progressed after at least one potent AR pathway inhibitor; excludes small cell/neuroendocrine histology and liver metastases. Evaluates pocenbrodib, an oral CBP/EP300 bromodomain inhibitor that suppresses AR/AR‑variant transcription, as monotherapy and in combination with abiraterone, olaparib, or 177Lu‑PSMA‑617.

ClinicalTrials.gov ID: NCT06785636

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