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

Cohort studyJournal of nuclear medicine : official publication, Society of Nuclear Medicine· Aug 2026

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

Clément Bailly, Lavinia Vija, François Somme … Guilhem Roubaud

Nuclear MedicineCohort studyTreatmentQ1IF 6.5

Real-world Lu-PSMA-617 achieved prostate-specific antigen disease control in 82% of patients

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

Clément Bailly … Guilhem Roubaud

Journal of nuclear medicine · Aug 2026 · Q1 in Radiology

Background

Metastatic castration-resistant prostate cancer (mCRPC) remains challenging to treat, especially after failure of standard therapies, such as androgen receptor pathway inhibitors and taxane-based chemotherapy.

Purpose

This analysis reports the largest real-world cohort of patients with mCRPC treated with [ 177 Lu]Lu-PSMA-617, evaluating its use, safety, and effectiveness in routine clinical practice.

Methods

Received up to 6 cycles of intravenous [ 177 Lu]Lu-PSMA-617 every 6 wk.

n = 3709 patients

82%

Results

82%

82% of real-world patients achieved disease control based on prostate-specific antigen criteria

n = 3709 patients

More results

From December 2021 to April 2025, 3709 patients from 46 centers received at least 1 dose and 2476 had more than 8 mo of follow-up for efficacy analysis.

Compared with VISION, patients were older, more heavily pretreated, and had more lymph node metastases but lower baseline prostate-specific antigen.

Median imaging PFS was 7.6 mo versus 8.7 mo in VISION.

More results

Some patients with early prostate-specific antigen progression after the first cycle subsequently showed a response, suggesting a flare-up effect.

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Conclusion · 1 of 2

The French early-access program confirms a favorable benefit-risk profile for [ 177 Lu]Lu-PSMA-617 in a real-world mCRPC population.

Conclusion · 2 of 2

Use trends suggest earlier use of the treatment after 1 taxane-based treatment, with patients being less pretreated and characterized by fewer metastases.

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

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

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