Clinical Trials for Prostate Cancer

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

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: This trial enrolls adults with advanced or metastatic, immunologically cold solid tumors—including biliary tract, HR-negative/HER2-positive breast, platinum-resistant ovarian, pancreatic adenocarcinoma, soft tissue sarcoma, castrate-resistant prostate, neuroendocrine, and vulvar cancers—who have progressed on or are intolerant to standard therapies. Patients receive atezolizumab (anti-PD-L1 immune checkpoint inhibitor) combined with tivozanib (oral VEGFR tyrosine kinase inhibitor), aiming to improve tumor response rates in this refractory population.

ClinicalTrials.gov ID: NCT05000294

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

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: This trial enrolls adults with advanced sarcoma, prostate, breast, ovarian, or pancreatic cancers who have progressed after prior systemic therapy, assigning individualized regimens—including targeted agents like CDK4/6 inhibitors (abemaciclib), PARP inhibitors (olaparib), EGFR inhibitors (gefitinib, osimertinib), endocrine therapies, and chemotherapeutics—based on serial molecular profiling and multidisciplinary tumor board review. Patients may switch treatments upon progression or toxicity according to ongoing molecular and proteomic data.

ClinicalTrials.gov ID: NCT06630325

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

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: Eligible patients are adults with unresectable or metastatic solid tumors harboring the AKT1 E17K mutation who have not previously received PI3K or mTOR inhibitors and have good performance status. The study tests ALTA2618, an oral, mutation-selective covalent allosteric inhibitor of AKT1 E17K.

ClinicalTrials.gov ID: NCT06533059

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

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: This trial enrolls adults with previously treated, castration-sensitive oligometastatic prostate adenocarcinoma (1-5 PET-detected bone or nodal/soft tissue metastases, including at least one extrapelvic), randomizing them to stereotactic ablative body radiation therapy (SABR) plus either relugolix (an oral GnRH receptor antagonist) or placebo for 6 months.

ClinicalTrials.gov ID: NCT05053152

Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (BAT-RAD 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 mCRPC with bone-predominant disease, asymptomatic/minimally symptomatic, castrate testosterone, prior exposure to ≤1 novel AR-targeted agent (and no visceral metastases) receive radium-223 plus Bipolar Androgen Therapy (testosterone cypionate). Radium-223 is an alpha-emitting bone-targeted radiopharmaceutical, and BAT cycles supraphysiologic testosterone to induce DNA damage and potentially re-sensitize AR signaling.

ClinicalTrials.gov ID: NCT04704505

LuCarbo - a Phase 1a/1b Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-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 progressive mCRPC post–ARPI and taxane, ECOG 0–2, PSMA-avid on 68Ga-PSMA PET, receive 177Lu-PSMA-617 radioligand therapy (targets PSMA to deliver beta radiation) combined with carboplatin DNA–crosslinking chemotherapy; prior PARPi/Ra-223 allowed, prior 177Lu-PSMA-617 excluded. Single-arm dose-escalation/expansion evaluates safety and preliminary efficacy, with carboplatin Days 1/22 and 177Lu-PSMA-617 Day 2 every 6 weeks for up to 6 cycles.

ClinicalTrials.gov ID: NCT06303713

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