Clinical Trials for Prostate Cancer

A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies

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.

HealthScout AI summary: Adults with metastatic CRPC, pancreatic cancer, or HPV-negative SCCHN lacking effective options receive triplet therapy with evofosfamide (hypoxia-activated DNA crosslinking prodrug) plus zalifrelimab (anti–CTLA-4) and balstilimab (anti–PD-1). Open-label dose-escalation followed by disease-specific expansions; key exclusions include significant prior immune toxicity, active autoimmune disease, QTc ≥470 msec/TdP risk, uncontrolled CNS disease/infections, and use of strong/moderate CYP3A4 modulators or QT-prolonging drugs.

ClinicalTrials.gov ID: NCT06782555

A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With 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.

HealthScout AI summary: Men with metastatic prostate adenocarcinoma, including mCRPC after prior therapies (and select high‑volume mCSPC for combination cohorts), receive the PSMA‑targeted antibody–drug conjugate ARX517 (anti‑PSMA ADC delivering the microtubule inhibitor amberstatin‑269) as monotherapy or combined with apalutamide or abiraterone/prednisone; PSMA positivity is required for alternative dosing and combination cohorts. The trial focuses on safety/PK and preliminary activity, with key exclusions including significant cardiac, pulmonary, ocular, or neurologic risks and prior restricted ARPI/taxane exposures depending on cohort.

ClinicalTrials.gov ID: NCT04662580

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination 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.

HealthScout AI summary: Adults with advanced solid tumors, including cohorts for mCRPC/mHSPC and EOC, eligible after or unsuitable for standard therapy (ECOG 0–1), receive the oral, selective PARP1 inhibitor M9466 as monotherapy, combined with the ATR inhibitor tuvusertib, or combined with abiraterone/prednisone for prostate cancer. Aims include safety/PK and preliminary activity, with particular interest in HRR/HRD tumors and potential synergy with ATR inhibition.

ClinicalTrials.gov ID: NCT06421935

Phase II Study of Apalutamide With Carotuximab 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.

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

HealthScout AI summary: Adults with metastatic castration‑resistant prostate cancer who have PSA progression on a prior AR signaling inhibitor (abiraterone, enzalutamide, or darolutamide) and are ineligible for or decline taxanes are randomized to apalutamide alone or apalutamide plus carotuximab. Carotuximab is an anti‑angiogenic monoclonal antibody against endoglin (CD105) on proliferating endothelium, added to test whether it improves radiographic PFS; crossover to the combination is allowed at progression.

ClinicalTrials.gov ID: NCT05534646

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

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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

HealthScout 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.

HealthScout 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