Clinical Trials for Prostate Cancer

Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer

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 locally advanced or metastatic prostate cancer (ECOG 0–1) with at least one MRI/CT-visible lesion receive intravenous hyperpolarized 13C-pyruvate followed by metabolic MR spectroscopic imaging to quantify pyruvate-to-lactate (glycolysis via LDH) and pyruvate-to-glutamate (TCA-linked) flux. Imaging is performed once or serially to assess intratumoral heterogeneity and early metabolic response to ongoing systemic therapy; no therapeutic intervention is assigned.

ClinicalTrials.gov ID: NCT04346225

A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

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 cancer after at least one taxane and one AR-targeted therapy (177Lu-PSMA-617 allowed; ECOG 0–2; excludes prior PD-1/PD-L1 progression or prior cabozantinib) receive cabozantinib 40 mg daily plus nivolumab 480 mg IV q4w. Cabozantinib is a multi-kinase inhibitor (MET/VEGFR2/AXL) with anti-angiogenic and bone microenvironment effects, combined with the PD-1 inhibitor nivolumab to potentially enhance immune response.

ClinicalTrials.gov ID: NCT05502315

An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.

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 progressive PSMA-positive mCRPC (ECOG 0–2) stratified by renal function (normal, moderate, severe impairment) receive lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617), a PSMA-targeted beta-emitting radioligand therapy, to assess biodistribution, dosimetry, PK, urinary excretion, and safety; dosing is 7.4 GBq q6 weeks (6 cycles for normal/moderate; 3 with possible extension in severe impairment). Excludes prior PSMA RLT and significant QT risk/medications during Cycle 1; all require PSMA-avid disease on 68Ga-PSMA-11 PET/CT.

ClinicalTrials.gov ID: NCT06004661

Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

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 cancer on ADT who had a poor response to prior abiraterone (e.g., short duration or no PSA50), ECOG 0–2, and no prior chemotherapy for mCRPC receive ruxolitinib (JAK1/2 inhibitor targeting JAK-STAT/inflammatory stem-like pathways) plus enzalutamide. Single-arm dose-escalation/expansion assesses safety and preliminary efficacy (PSA50, RECIST responses, PFS); key exclusions include untreated brain mets, recent major CV/thromboembolic events, active hepatitis/TB, and seizure history.

ClinicalTrials.gov ID: NCT06616155

A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

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 previously treated, hormone-sensitive oligometastatic prostate adenocarcinoma (1–5 PSMA-PET–avid lesions amenable to SBRT) receive fractionated 177Lu-PSMA-617 followed by SBRT (9 Gy × 3) to all sites. 177Lu-PSMA-617 is a PSMA-targeted beta-emitting radioligand delivering lutetium-177 to PSMA-expressing cells; the study evaluates safety/feasibility of this combination in the HSPC, oligometastatic setting.

ClinicalTrials.gov ID: NCT05079698

A Phase 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

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: Biomarker-selected mCRPC (adenocarcinoma or small cell) after at least one AR pathway inhibitor, requiring dMMR/MSI-H or CDK12-altered tumors (NGS-defined), ECOG 0–1, and castrate testosterone. Single-arm pembrolizumab 200 mg IV q3w (anti–PD-1 immune checkpoint inhibitor) continued with ongoing ADT; excludes prior PD-1/PD-L1/CTLA-4 therapy and active autoimmune disease.

ClinicalTrials.gov ID: NCT04104893

Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I/II Trial

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: Adults with advanced solid tumors lacking options (phase I) and an expansion in relapsed/advanced prostate cancer (phase II), ECOG 0–2, receive an oral combination targeting autophagy and growth-survival pathways: hydroxychloroquine (lysosomal/autophagy inhibitor), sirolimus (mTORC1 inhibitor), metformin (AMPK activation/indirect mTOR suppression), with stepwise addition of dasatinib (Src/Abl inhibitor) and/or nelfinavir (HIV protease inhibitor causing ER stress/PI3K–AKT inhibition). Phase II focuses on 16-week disease control in prostate cancer at the RP2D.

ClinicalTrials.gov ID: NCT05036226

High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency

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: Enrolling men with metastatic castration-resistant prostate cancer who have inactivating mutations in ATM, CDK12, or CHEK2 after prior next-generation AR-signaling inhibitor, asymptomatic/minimally symptomatic, ECOG 0–1. Patients receive bipolar androgen therapy (intermittent high-dose testosterone while maintaining castration) to exploit DNA damage/replication stress and AR signaling disruption, hypothesized to be particularly active in DDR-deficient tumors.

ClinicalTrials.gov ID: NCT05011383

A Phase I/II Study to Determine the Safety and Efficacy of a Combination of Green Tea and Quercetin With Docetaxel in Castration-resistant Prostate Cancer Patients

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 progressing on continuous ADT and prior AR pathway inhibitors, eligible to start docetaxel/prednisone, are randomized to docetaxel/prednisone plus green tea extract and quercetin versus placebo. The investigational add-on comprises dietary polyphenols (EGCG-rich green tea extract and quercetin) with proposed chemosensitizing/anti-tumor activity via signaling, oxidative stress, and drug transport/metabolism modulation; the study evaluates PSA response, radiographic outcomes, safety, and pharmacokinetics.

ClinicalTrials.gov ID: NCT06615752

A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer

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: Metastatic castration-resistant prostate cancer progressing on prior taxane therapy (docetaxel or cabazitaxel); ECOG 0–2. Adds high-dose omeprazole (repurposed fatty acid synthase inhibitor) to ongoing cabazitaxel or docetaxel to assess radiographic response, PSA/pain outcomes, and pharmacodynamic target engagement.

ClinicalTrials.gov ID: NCT04337580