TheranosticTrials.org

Clinical Trial · NCT06303713

LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

Overview

The purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer. The names of the study drugs used in this research study are: * Carboplatin (A type of chemotherapy) * 177Lu-PSMA-617 (A type of radioligand therapy)

Sponsor

Dana-Farber Cancer Institute

Phase

Phase 1

Contacts

Praful Ravi, MB BCHir, MRCP (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06303713

Drug / Compound

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Hepatic
  • Sequence of at least 2 rising PSA values at a minimum of 1-week intervals with the last result being ≥1.0 ng/mL if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen (flutamide, bicalutamide or nilutamide) must have PSA progression ≥4 weeks after the last dose.
  • Participants who have previously received 177Lu-PSMA-617.
  • Hemoglobin ≥9g/dL (≥90g/L), independent of transfusions
  • Prior receipt of at least one taxane chemotherapy (docetaxel or cabazitaxel) and at least one ARPI (abiraterone, enzalutamide, apalutamide or darolutamide) in the localized, recurrent or metastatic setting. Prior treatment with a PARP inhibitor(s) is permitted. Prior treatment with Ra-223 is permitted, providing that the last dose of Ra-223 was ≥90 days prior to study entry.

Exclusion

Exclusion criteria not yet provided.