OncoMatch/Clinical Trials/NCT06738303
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
Is NCT06738303 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Cabazitaxel and carboplatin and Lu-PSMA-617 for metastatic prostate cancer.
Treatment: Cabazitaxel and carboplatin · Lu-PSMA-617 — The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) psma-positive by 18f-rhpsma-7.3 pet (≥1 site with suvmax ≥10) (SUVmax ≥10)
Patients must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10. An alternative PSMA PET tracer is permitted at baseline if performed within 8 weeks prior to randomization.
Required: TP53 mutation
one of the following (using Next Generation Sequencing on file within 5 years): TP53, PTEN mutation
Required: PTEN mutation
one of the following (using Next Generation Sequencing on file within 5 years): TP53, PTEN mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen receptor pathway inhibitor
previously been treated with an androgen receptor pathway inhibitor
Lab requirements
Blood counts
ANC >1000/μL; platelet count >90,000/μL; hemoglobin >8.5 g/dL; no growth factors within 7 days or blood transfusions within 14 days prior to screening labs; albumin >30 g/L (3.0 g/dL)
Kidney function
Creatinine clearance ≥40 mL/min and/or eGFR ≥30
Liver function
Total bilirubin <2.5 × ULN (except Gilbert syndrome <3 mg/dL); ALT and AST <5 × ULN
Participants must have adequate organ and marrow function as defined below to be suitable for the randomized treatment outlined in this
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center · Cleveland, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06738303 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received androgen receptor pathway inhibitor.
Does this trial require FOLH1?
Yes, FOLH1 psma-positive by 18f-rhpsma-7.3 pet (≥1 site with suvmax ≥10) is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require PTEN?
Yes, PTEN mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify