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Radioligand Therapy

Carboplatin + 177Lu-PSMA-617 for Prostate Cancer

Phase 1
Recruiting
Led By Praful Ravi, MB BCHir, MRCP
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to determine if a combination of chemotherapy drug, carboplatin, and radioligand treatment, 177Lu-PSMA-617, is safe and effective in treating prostate cancer

Who is the study for?
This trial is for men with metastatic castrate-resistant prostate cancer. Participants should not have had previous chemotherapy for their condition and must be able to perform daily activities without significant assistance.
What is being tested?
The study is testing the safety and effectiveness of combining a chemotherapy drug, Carboplatin, with a radioligand therapy called 177Lu-PSMA-617 in treating advanced prostate cancer.
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, kidney issues from the radioligand therapy, and allergic reactions to the chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617
Secondary study objectives
Overall Response Rate (ORR)
Overall Survival (OS)
PSA response rate (PSA reduction by ≥50% from baseline).
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 1B: Dose ExpansionExperimental Treatment2 Interventions
19 additional participants will be enrolled at the RP2D of carboplatin and will complete: * Baseline visit. * Day 1 of Cycles 3 and 5: Tumor assessment radiologic scans. * Tumor biopsy at baseline and at 12 weeks. * Cycle 1 through End of Treatment: * Days 1 and 22 of 42 day cycle: Predetermined dose of carboplatin every 3 weeks for a maximum of up to 6 cycles. * Day 2 of 42 day cycle: Predetermined dose of 177Lu-PSMA-617 every 6 weeks for a maximum of up to 6 cycles. * End of treatment visit. * Follow up visits in-office or via telephone.
Group II: Phase 1A: Dose EscalationExperimental Treatment2 Interventions
Participants will be enrolled in a 3+3 dose escalation design to establish a maximum tolerated dose (MTD) of carboplatin, starting at Dose Level 1 and escalating to Dose Level 2 or 3. * Baseline visit. * Day 1 of Cycles 3 and 5: Tumor assessment radiologic scans. * Cycle 1 through End of Treatment: * Days 1 and 22 of 42-day cycle: Predetermined dose of carboplatin every 3 weeks for a maximum of up to 6 cycles. * Day 2 of 42-day cycle: Predetermined dose of 177Lu-PSMA-617 every 6 weeks for a maximum of up to 6 cycles. * End of treatment visit. * Follow up visits in-office or via telephone. If 0 out of 3 participants experience a dose-limiting toxicity (DLT), the study will proceed to the next dose level. If 1 or more participants experience a DLT, this dose level is declared the MTD and study will not proceed to expansion. If 1 out of 6 participants at the highest dose level experience DLTs, this is the recommended Phase 1B dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
177Lu-PSMA-617
2018
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,105 Previous Clinical Trials
359,448 Total Patients Enrolled
71 Trials studying Prostate Cancer
14,635 Patients Enrolled for Prostate Cancer
NovartisIndustry Sponsor
1,633 Previous Clinical Trials
2,729,121 Total Patients Enrolled
21 Trials studying Prostate Cancer
4,897 Patients Enrolled for Prostate Cancer
Praful Ravi, MB BCHir, MRCPPrincipal InvestigatorDana-Farber Cancer Institute
~25 spots leftby Jul 2026
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