All Trials

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.

TrialFetch 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.

TrialFetch 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

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

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.

TrialFetch AI summary: Veterans with oligometastatic or oligo-recurrent prostate cancer (1–10 PSMA/fluciclovine/choline PET-detected lesions; ECOG ≤2) are randomized to standard systemic therapy (ADT ± first-generation antiandrogen; optional intensification with docetaxel, abiraterone, apalutamide, or enzalutamide; de novo cases also get prostate RT) with or without PET-directed local therapy to all sites (SBRT/surgery and salvage local therapy when feasible). No investigational drugs; compares addition of metastasis-directed therapy to contemporary systemic care.

ClinicalTrials.gov ID: NCT04787744

A Phase 2 Study of Pembrolizumab Plus 177Lu-PSMA-617 in Patients 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.

TrialFetch AI summary: Men with mCRPC after ≥1 second-generation ARSI (± up to two taxane lines), PSMA-PET–avid disease, and ECOG 0–1 receive pembrolizumab (PD‑1 inhibitor) plus 177Lu‑PSMA‑617 radioligand therapy, with two initial Lu‑PSMA doses then adaptive re-dosing at PSA rise until progression/toxicity. Excludes prior PSMA-directed therapy or checkpoint inhibitors; allows treated/stable brain metastases.

ClinicalTrials.gov ID: NCT05766371

Phase 1/2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC

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.

TrialFetch AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma after ≥2 prior lines (including a next-generation AR inhibitor) and castrate testosterone receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous STEAP1-directed CAR T cells plus continuous enzalutamide. The investigational product is a CAR T therapy targeting STEAP1 to direct T‑cell cytotoxicity against STEAP1-expressing tumors; key exclusions include active autoimmune disease requiring immunosuppression, uncontrolled infection, and untreated/symptomatic brain metastases.

ClinicalTrials.gov ID: NCT06236139

First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in 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.

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma after at least one prior systemic therapy undergo [68Ga]Ga DOTA-5G PET/CT selection, then receive [177Lu]Lu DOTA-ABM-5G radioligand therapy. The investigational theranostic pair targets DOTA-5G–avid lesions to confirm uptake for enrollment and deliver lutetium-177 beta radiation to tumors.

ClinicalTrials.gov ID: NCT04665947