Clinical Trials for Prostate Cancer

A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With 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: Chemo‑naïve adults with PSMA‑positive metastatic castration‑resistant prostate cancer after progression on exactly one second‑generation ARPI (ECOG 0–1, adequate renal function) receive lutetium‑177 vipivotide tetraxetan (PSMA‑targeted beta‑emitting radioligand therapy) 7.4 GBq IV every 6 weeks for up to 12 cycles with continued androgen deprivation. Prior radioligand therapy, prior mCRPC chemotherapy, significant renal impairment, and use of targeted agents (e.g., PARP inhibitors) are excluded.

ClinicalTrials.gov ID: NCT06531499

177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan

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: Single-arm study of 177Lu-PSMA-617 radioligand therapy (targets PSMA to deliver beta-emitting lutetium-177) in adult men with PSMA-positive mCRPC who have extensive bone involvement presenting as a super scan on 99mTc bone scan, after at least one AR pathway inhibitor. Patients receive up to six IV cycles every ~6 weeks with dose-escalation to define optimal dosing in this previously excluded, heavily bone-dominant population.

ClinicalTrials.gov ID: NCT06972628

SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed 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: Men with de novo metastatic prostate adenocarcinoma (M1a–M1c), ECOG 0–1, starting or within 6 months of ADT, are randomized to best systemic therapy (ADT ± docetaxel) with or without cytoreductive radical prostatectomy. Docetaxel (taxane microtubule inhibitor) may be given before surgery; outcomes include failure-free survival, survival endpoints, complications, and quality of life.

ClinicalTrials.gov ID: NCT03456843

Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for 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.

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 mCRPC (ECOG 0–1) with ≥2 bone metastases, castrate testosterone, and no extensive visceral disease are randomized to docetaxel/prednisone versus docetaxel plus radium‑223. Radium‑223 is an alpha‑emitting bone‑targeted radiopharmaceutical delivering high‑LET radiation to bone metastases; the trial tests whether adding it to docetaxel improves overall survival.

ClinicalTrials.gov ID: NCT03574571

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

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