Reston, VA (October 22, 2026)—Prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical therapy is safe and effective for patients with metastatic castration-resistant prostate cancer (mCRPC) in routine clinical practice, consistent with outcomes from the landmark VISION trial. An analysis of outcomes from a French early-access program, the largest real-world cohort of patients studied to date, confirms the benefit-risk profile of the therapy, while also shedding light on patient selection and use trends. This research was published in The Journal of Nuclear Medicine.
PSMA-targeted radiopharmaceutical therapy has emerged as a novel treatment modality for mCRPC patients whose disease has progressed after receiving standard therapies. It was studied extensively in the VISION clinical trial, and in 2022, 177Lu-PSMA-617 became the first radiopharmaceutical therapy approved to treat prostate cancer.
"Although the VISION clinical trial demonstrated the safety and efficacy of 177Lu-PSMA-617 in a selected population, there is a need for complementary real-world data to understand its use and outcomes in routine clinical practice among broader and more diverse patient populations," said Clément Bailly, MD, PhD, nuclear medicine physician in Nantes University Hospital in France. "France's early-access program provided a valuable opportunity to evaluate the safety and efficacy of 177Lu-PSMA-617 in a real-world setting."
From December 2021 to April 2025, the early-access program enrolled 3,709 patients with mCRPC across 46 centers in France. All patients had progressive disease after receiving at least one standard treatment. Through the early-access program, the patients received up to six cycles of 177Lu-PSMA-617. Clinical evaluation, prostate-specific antigen (PSA) status, imaging assessments, and treatment-related adverse events were collected during regular follow-up. Progression-free survival and overall survival outcomes were assessed and compared to those in the VISION trial.
Patients in the early-access program were older, more heavily pretreated, and had more lymph node metastases but lower baseline PSA in comparison to those in the VISION trial. Median progression-free survival was 7.6 months versus 8.7 months in VISION. Disease control was achieved in 82 percent of the French cohort according to PSA criteria.
In addition, the early-access program provided robust characterization of several important findings:
- Subgroup analyses confirmed efficacy in older patients and more favorable outcomes in patients less heavily pretreated with taxane-based chemotherapy.
- A "flare-up" phenomenon was noted, in which patients experienced PSA progression after the first cycle of 177Lu-PSMA-617, followed by PSA decline after the second cycle.
- Clinicians progressively treated patients with less advanced disease and lower levels of prior treatment exposure, suggesting that as experience with radiopharmaceutical therapy grew, providers became more comfortable incorporating the therapy earlier in the treatment journey.
"This real-world data confirms that the benefits seen in the VISION trial translate into routine clinical practice," said Guilhem Roubaud, MD, a medical oncologist in Institut Bergonié in Bordeaux, France. "For patients with advanced prostate cancer, this study means earlier access to a potentially life-extending treatment when options are limited, adding value to the French Early Access program in delivering both rapid access to innovation and robust evidence to inform future clinical practice for patients and healthcare decisions whenever possible."
The authors of " Real-World Outcomes of [177Lu]Lu-PSMA-617 in the French Early-Access Program for Patients with Metastatic Castration-Resistant Prostate Cancer " include Clément Bailly, Nuclear Medicine Department, Nantes University Hospital, Nantes, France; Lavinia Vija, Department of Nuclear Medicine, Oncopole Claudius Regaud, Toulouse, France; François Somme, Nuclear Medicine and Molecular Imaging, Institut Strauss, Strasbourg, France; Vincent Massard, Medical Oncology Department, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France; Philippe Barthélémy, Department of Medical Oncology, University Hospital Strasbourg, Strasbourg, France; Anne-Laure Giraudet, Lumen Nuclear Medicine Department, Centre Léon Bérard, Lyon, France; Yann Godbert, Department of Thyroid Oncology and Nuclear Medicine, Institut Bergonié, Bordeaux, France; Aude Fléchon, Department of Medical Oncology, Urological Oncology Centre Léon Bérard, Lyon, France; Sylvie Girault, Department of Nuclear Medicine, ICO Pays de la Loire, Angers, France; Sophie Abadie-Lacourtoisie, ICO Paul Papin, Angers, France; Caroline Viala, Nantes University Hospital, Nantes, France; Alix Douillet and Stephanie Chêne, Medical Department, Novartis, Rueil-Malmaison, France; Pierre Olivier, Department of Nuclear Medicine, CHRU Nancy, Nancyclotep Imaging Platform, Nancy, France; and Guilhem Roubaud, Department of Medical Oncology, Institut Bergonié, Bordeaux, France.
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