Clinical Trials for Prostate Cancer

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib 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.

HealthScout AI summary: Men with progressive metastatic castration‑resistant prostate adenocarcinoma after one next‑generation AR pathway inhibitor, ECOG 0–1, receive gedatolisib (investigational pan‑class I PI3K/mTORC1/2 inhibitor) plus darolutamide. Excludes prior PI3K/AKT/mTOR therapy or mCRPC chemo/radiopharmaceuticals; continued ADT required.

ClinicalTrials.gov ID: NCT06190899

Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

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 after at least one AR pathway agent, ECOG 0–1, and ongoing castration (no prior PD‑1/PD‑L1 therapy) receive pembrolizumab plus a standard AR pathway inhibitor, randomized to add a single dose of 225Ac-J591. 225Ac-J591 (rosopatamab tetraxetan) is a PSMA-targeted monoclonal antibody radioimmunotherapy delivering alpha-emitting actinium-225 to PSMA-expressing tumor cells.

ClinicalTrials.gov ID: NCT04946370

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

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: Enrolling adult men with metastatic aggressive variant prostate cancer (including small cell/neuroendocrine features, visceral-only disease, lytic bone mets, low-PSA/high-volume disease, elevated LDH/CEA, rapid CR, or TP53/RB1/PTEN loss) and ECOG ≤2, without prior platinum or cabazitaxel for CRPC. Investigational triplet of ADI-PEG20 (pegylated arginine deiminase; depletes extracellular arginine exploiting ASS1 loss) plus carboplatin and cabazitaxel, followed by ADI-PEG20 maintenance.

ClinicalTrials.gov ID: NCT06085729

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects 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.

HealthScout AI summary: Men with metastatic castration‑resistant prostate adenocarcinoma, including post–ARPI and typically post‑taxane (with expansion cohorts allowing taxane‑naïve or limited prior therapies), receive JANX007, a protease‑activatable PSMA×CD3 T‑cell engager designed to limit systemic T‑cell activation; an expansion cohort combines JANX007 with darolutamide. Excludes prior PSMA‑directed cellular/bispecific or radioligand therapies and significant comorbidities.

ClinicalTrials.gov ID: NCT05519449

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