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Clinical Trial Summary

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)


Clinical Trial Description

This is a phase 1 dose-escalation and dose-expansion trial of carboplatin in combination with 177Lu-PSMA-617 in participants with metastatic castrate-resistant prostate cancer (mCRPC). The study will take place in two parts: Phase 1a to define the recommended phase 2 dose (RP2D) and Phase 1b to further assess safety and preliminary clinical activity of the combination regimen. The U.S. Food and Drug Administration (FDA) has not approved carboplatin for prostate cancer but it has been approved for other uses. The U.S. FDA has approved 177Lu-PSMA-617 as a treatment option for prostate cancer. The research study procedures include screening for eligibility and study treatment visits, tumor biopsies, x-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, and blood tests. It is expected that about 35 people will take part in this research study. Novartis is supporting this research study by providing 177Lu-PSMA-617, as well as research funding. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06303713
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Praful Ravi, MB BCHir, MRCP
Phone 617-632-3466
Email Praful_Ravi@DFCI.HARVARD.EDU
Status Recruiting
Phase Phase 1
Start date May 22, 2024
Completion date July 19, 2026

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