NCT06303713

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

LuCarbo - a Phase 1a/1b Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Prostate Cancer
• Metastatic Prostate Cancer
• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Platinum coordination compound, premixed aqueous solution of 10mg/ML, via intravenous (into the vein) infusion per protocol.
DRUG	177Lu-PSMA-617	Radioligand therapy, single-dose vial, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2024-05-22
• Primary completion: 2026-10-19
• Completion: 2027-03-19
• First posted: 2024-03-12
• Last updated: 2026-04-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study