Clinical Trials for Prostate Cancer

SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity

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 mCRPC progressing on next‑generation AR pathway inhibitors (maintained on ADT; no prior chemo for mCRPC) receive bipolar androgen therapy with supraphysiologic testosterone combined with either carboplatin, etoposide, or 177Lu‑PSMA‑617 (PSMA‑PET positive required for LuPSMA cohort), exploring synergy via DNA damage and PSMA modulation. Excludes patients with high VTE/cardiovascular risk or other contraindications to testosterone; outcomes focus on PSA50 response and disease control.

ClinicalTrials.gov ID: NCT06039371

A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ 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: Adults with PSCA-expressing metastatic castration-resistant prostate cancer after at least one next-generation AR pathway inhibitor receive lymphodepleting chemotherapy followed by autologous PSCA-directed CAR T cells (4-1BB/CD3ζ with CD19t tag), with an optional cohort adding metastasis-directed radiation (16 Gy in 2 fractions) before lymphodepletion. Key aims are safety/feasibility and preliminary activity, with allowance for up to three CAR T infusions per course.

ClinicalTrials.gov ID: NCT05805371

A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic 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: Asymptomatic men with mCRPC progressing on abiraterone plus ongoing ADT (testosterone <50 ng/dL), ECOG 0–2, and no prior AR antagonists or CRPC chemotherapy are randomized to continuous enzalutamide vs alternating cycles of supraphysiologic testosterone cypionate (bipolar androgen therapy; induces AR feedback disruption/DNA damage with potential AR re-sensitization) and enzalutamide, including a PSA-driven switching arm. Continues until clinical or radiographic progression; excludes patients with cancer-related pain, high thromboembolic risk, or conditions that increase risk from testosterone.

ClinicalTrials.gov ID: NCT04363164

A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)

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 PSMA-PET–positive mCRPC after at least one ARSI and one chemotherapy (ECOG 0–2) are randomized to 177Lu-PSMA-617 (vipivotide tetraxetan), a PSMA-targeted radioligand delivering lutetium-177 beta radiation, given either on a response-adapted flexible schedule with possible holidays and up to 12 cycles vs the standard six cycles every six weeks. Key exclusions include prior 177Lu-PSMA-617 and significant urinary obstruction/hydronephrosis.

ClinicalTrials.gov ID: NCT06216249

Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease

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 biopsy-proven local recurrence of prostate cancer after prior definitive radiation (± limited metastases), good performance status, IPSS <15, and prostate volume <50 cc receive salvage prostate brachytherapy combined with intraprostatic adenoviral HSV‑tk gene therapy plus short-course oral valacyclovir. The investigational HSV‑tk/valacyclovir suicide gene therapy targets HSV‑tk–expressing tumor cells to activate nucleoside analog cytotoxicity with potential bystander/immune effects; symptomatic metastatic disease and significant immunosuppression are excluded.

ClinicalTrials.gov ID: NCT01913106

A Phase I/II Study of Enzalutamide in Combination With Indomethacin in Castration-Resistant Prostate Cancer (CRPC)

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 castration-resistant prostate cancer (metastatic, recurrent, or PSA-only progression) receive enzalutamide plus indomethacin, a COX-inhibiting NSAID used investigationally to suppress prostaglandin-mediated AR signaling and potentially enhance AR blockade. Key exclusions include prior enzalutamide, seizure risk, GI bleeding/peptic ulcer disease, recent chemo/radiation, and significant cardiovascular or uncontrolled symptomatic disease.

ClinicalTrials.gov ID: NCT02935205

An Open-label, Phase I/IIa Dose Escalation and Expansion Study to Determine the Safety and Clinical Activity of an Immune Priming Cell Therapy (INKmune) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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: Men with progressive mCRPC after ADT and at least one AR signaling inhibitor (ECOG 0–1, no neuroendocrine/small cell histology) receive INKmune, a replication‑incompetent tumor cell product that primes endogenous NK cells to a memory‑like, cytotoxic phenotype, given as three weekly IV infusions with dose escalation/expansion. Key endpoints include NK activation, PSA declines, PSMA PET and ctDNA changes, and safety.

ClinicalTrials.gov ID: NCT06056791

AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease

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 characterized by non-measurable disease (often bone-predominant) after at least one novel hormonal agent, ECOG 0–2, and no prior PD-(L)1, CTLA-4, cabozantinib, or mCRPC chemotherapy. Patients receive cabozantinib (multi-kinase TKI targeting MET/VEGFR2/AXL) daily plus atezolizumab (anti–PD-L1) IV every 21 days until progression/toxicity.

ClinicalTrials.gov ID: NCT05168618

A Phase 2 Umbrella Protocol of Enfortumab Vedotin as Monotherapy and Combined With Other Agents in Patients With Metastatic 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: For men with metastatic castration-resistant prostate adenocarcinoma after ≥1 novel hormonal therapy and prior taxane, ECOG 0–2, this study tests enfortumab vedotin given D1/8/15 q28d. Enfortumab vedotin is a Nectin‑4–targeted antibody–drug conjugate delivering MMAE; initial cohort is monotherapy with potential future combination cohorts.

ClinicalTrials.gov ID: NCT04754191

Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study

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 castration-sensitive biochemical recurrence after prostatectomy and prior adjuvant/salvage RT, negative on conventional imaging but with PSMA or fluciclovine PET/CT stratification, receive either surveillance (PET confined to fossa), metastasis-directed therapy to ≤3 lesions plus abiraterone/prednisone, or abiraterone/prednisone alone (>3 regions). Abiraterone is a CYP17A1 inhibitor that suppresses androgen biosynthesis; outcomes include undetectable PSA at 2 years and time to systemic therapy.

ClinicalTrials.gov ID: NCT04175431