All Trials

Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) 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.

TrialFetch AI summary: Asymptomatic men with mCRPC progressing after abiraterone (ECOG 0–2) receive sequential cycles of DFMO (eflornithine; irreversible ornithine decarboxylase inhibitor targeting polyamine synthesis) with high‑dose testosterone (BAT) followed by enzalutamide, while continuing castration. Prior AR-targeted agents, taxanes, PARP inhibitors, radiopharmaceuticals, and prior BAT are allowed; key exclusions include opioid-requiring pain, high-flare risk sites, significant hearing loss, and seizure risk.

ClinicalTrials.gov ID: NCT06059118

Bipolar Androgen Therapy in 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.

TrialFetch AI summary: Adults with mCRPC progressing on continuous androgen suppression after at least one AR signaling inhibitor and one chemotherapy, with measurable and biopsiable disease, receive bipolar androgen therapy: intramuscular testosterone cypionate every 28 days for 3 cycles while maintaining medical castration with leuprolide. The approach cycles testosterone from castrate to supraphysiologic levels to modulate androgen receptor signaling and potentially re-sensitize tumors, with assessments of AR activity, PSA response, and safety.

ClinicalTrials.gov ID: NCT06305598

Vorinostat to Augment Response to 177Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low 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.

TrialFetch AI summary: Adults with PSMA-low mCRPC after at least one ARSI and one taxane receive a 28-day lead-in of vorinostat (HDAC inhibitor intended to upregulate PSMA) with PET reassessment, followed by standard 177Lu-PSMA-617 radioligand therapy for eligible converters. Aims to determine conversion to PSMA-high and subsequent antitumor activity and safety of the combination.

ClinicalTrials.gov ID: NCT06145633

A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

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.

TrialFetch AI summary: Adults with mCRPC after prior docetaxel (no prior cabazitaxel/carboplatin), adequate organ function, and available tissue for central AVPC molecular-pathologic signature (TP53/RB1/PTEN by IHC) are randomized to cabazitaxel plus prednisone with or without carboplatin. The study tests whether adding carboplatin (DNA crosslinking platinum) to cabazitaxel (microtubule inhibitor) improves rPFS, with primary focus on AVPC-MS–positive disease.

ClinicalTrials.gov ID: NCT06470243

Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate 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.

TrialFetch AI summary: Adults with PSMA-positive metastatic castration-resistant prostate cancer at Mayo Clinic Rochester who achieve a near-complete response on post-therapy SPECT after initial 177Lu-PSMA-617 are randomized to continue standard 177Lu-PSMA-617, pause after 5 cycles with retreatment at progression, or initial observation with deferred 177Lu-PSMA-617 at first progression. 177Lu-PSMA-617 is a PSMA-targeted radioligand therapy delivering beta radiation to PSMA-expressing cells; the trial tests whether imaging-guided de-escalation maintains disease control while reducing exposure.

ClinicalTrials.gov ID: NCT06200103

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

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.

TrialFetch AI summary: Men with metastatic castration-sensitive prostate adenocarcinoma starting or on first-line intensified ADT (abiraterone, apalutamide, enzalutamide, or darolutamide; with or without prior chemotherapy) are randomized to monthly 5-day fasting-mimicking diet vs standard diet added to standard-of-care. Evaluates impact on PSA response and metabolic outcomes; excludes underweight patients, unstable diabetes, significant comorbidities, recent major weight loss, or regular fasters.

ClinicalTrials.gov ID: NCT05832086

A Single Arm Open-label, Phase II Study of Sipuleucel-T with Bipolar Androgen Therapy in Men 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.

TrialFetch AI summary: Men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (ECOG 0–1, castrate testosterone) receive bipolar androgen therapy with intramuscular testosterone cypionate plus standard sipuleucel-T. Sipuleucel-T is an autologous APC-based vaccine activated ex vivo with PA2024 (PAP–GM-CSF) and BAT provides cyclical supraphysiologic testosterone to stress tumor cells; the study targets immunologic enhancement and assesses PSA/radiographic outcomes.

ClinicalTrials.gov ID: NCT06100705

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

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.

TrialFetch AI summary: Men with asymptomatic or minimally symptomatic metastatic castrate‑resistant prostate cancer who have completed the standard three infusions of sipuleucel‑T (PROVENGE) are randomized to receive a single booster sipuleucel‑T infusion at 6–9 months versus no booster. Sipuleucel‑T is an autologous cellular immunotherapy activating APCs with a PAP–GM‑CSF fusion protein (PA2024); the study assesses boosted immune responses and clinical outcomes, including overall survival.

ClinicalTrials.gov ID: NCT06134232

ParpVax2: A Phase II Study Of Maintenance Niraparib Plus Ipilimumab In Patients With Metastatic Pancreatic Cancer Whose Disease Has Not Progressed On Platinum-Based Therapy

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.

TrialFetch AI summary: Adults with metastatic pancreatic adenocarcinoma with at least stable disease after 8–12 cycles of platinum-based induction (FOLFIRINOX or NALIRIFOX; ECOG 0–1) are randomized to maintenance niraparib (PARP-1/2 inhibitor) plus ipilimumab (CTLA-4 inhibitor) versus continued chemotherapy (FOLFIRI). Key exclusions include prior PARP/CTLA-4 therapy, known pathogenic BRCA1/2/PALB2/RAD51C/D alterations, and dMMR/MSI-H disease.

ClinicalTrials.gov ID: NCT06747845

A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic 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.

TrialFetch AI summary: Adults with untreated, biopsy-proven metastatic pancreatic adenocarcinoma (ECOG 0–1) receive first-line gemcitabine plus nab-paclitaxel combined with the TheraBionic device, which delivers low-intensity, amplitude‑modulated radiofrequency electromagnetic fields intended to modulate tumor cell signaling and calcium channel activity. Key exclusions include prior systemic therapy for metastatic disease, recent adjuvant/neoadjuvant gemcitabine or nab-paclitaxel, brain metastases, significant cardiopulmonary disease, and concurrent use of L-/T-type calcium channel blockers unless discontinued.

ClinicalTrials.gov ID: NCT05776524