Real-World Outcomes of [¹⁷⁷Lu]Lu-PSMA-617 in the French Early-Access Program for Patients with Metastatic...

Area of Science:

• Oncology
• Nuclear Medicine
• Radiopharmaceutical Therapy

Background:

• Metastatic castration-resistant prostate cancer (mCRPC) presents significant treatment challenges, particularly after standard therapies fail.
• Lutetium (¹⁷⁷Lu) PSMA-617 targets prostate-specific membrane antigen (PSMA)-positive mCRPC cells and has shown promise in clinical trials.
• An early-access program in France provided real-world data on ¹⁷⁷Lu]Lu-PSMA-617 use.

Purpose of the Study:

• To evaluate the real-world effectiveness and safety of ¹⁷⁷Lu]Lu-PSMA-617 in a large cohort of mCRPC patients.
• To compare outcomes with the VISION trial and identify trends in treatment utilization.
• To assess the benefit-risk profile in routine clinical practice.

Main Methods:

• A multicenter descriptive cohort study of 3709 mCRPC patients treated with ¹⁷⁷Lu]Lu-PSMA-617.
• Patients had progressive disease after standard therapies and a positive PSMA PET scan.
• Prospective collection of clinical, PSA, imaging, and safety data; PFS analyzed using Kaplan-Meier methods.

Main Results:

• Median imaging progression-free survival (PFS) was 7.6 months, comparable to the VISION trial.
• Disease control was achieved in 82% based on PSA criteria; a flare-up effect was observed in some patients.
• The safety profile was manageable, with efficacy confirmed in elderly patients and those less heavily pretreated.

Conclusions:

• The French early-access program confirms the favorable benefit-risk profile of ¹⁷⁷Lu]Lu-PSMA-617 for mCRPC in a real-world population.
• Treatment trends suggest earlier utilization after taxane-based chemotherapy.
• ¹⁷⁷Lu]Lu-PSMA-617 demonstrates effectiveness and manageable safety in routine clinical practice.