Real-World Outcomes of PSMA-Targeted Therapy for mCRPC Affirmed in French Study

Prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical therapy has proven to be both safe and effective for patients suffering from metastatic castration-resistant prostate cancer (mCRPC) in routine clinical settings, as demonstrated by an analysis of data from France's early-access program. This study aligns with findings from the pivotal VISION trial and was published in The Journal of Nuclear Medicine.

The analysis examines the largest real-world cohort to date, comprising 3,709 patients enrolled from December 2021 to April 2025 across 46 centers in France. Participants had mCRPC and had shown disease progression after receiving at least one standard treatment. The patients received up to six cycles of 177Lu-PSMA-617, the first radiopharmaceutical therapy approved for prostate cancer in 2022. Regular follow-ups included clinical evaluations, prostate-specific antigen (PSA) levels, imaging assessments, and monitoring for treatment-related adverse events.

Results indicate that patients in the early-access program were generally older, more heavily pretreated, and had a higher incidence of lymph node metastases compared to those in the VISION trial. Notably, the median progression-free survival was observed at 7.6 months, slightly below the 8.7 months reported in VISION, while disease control was noted in 82% of the French cohort based on PSA criteria.

Further findings from the study revealed that subgroup analyses confirmed higher efficacy in older patients and suggested more favorable outcomes for those who had undergone less prior treatment, particularly with taxane-based chemotherapy. Interestingly, a “flare-up” phenomenon was noted, where patients experienced an initial PSA increase after the first cycle of 177Lu-PSMA-617, followed by a decline after the second cycle.

The report also highlights a trend for clinicians to utilize 177Lu-PSMA-617 earlier in the treatment progression as their experience with radiopharmaceuticals grew. This shift suggests greater comfort in applying the therapy to patients with less advanced disease and lower prior treatment exposure.

Guilhem Roubaud, MD, stated, "This real-world data confirms that the benefits seen in the VISION trial translate into routine clinical practice. For patients with advanced prostate cancer, this study means earlier access to a potentially life-extending treatment when options are limited."

The full report titled "Real-World Outcomes of [177Lu]Lu-PSMA-617 in the French Early-Access Program for Patients with Metastatic Castration-Resistant Prostate Cancer" includes contributions from Clément Bailly and other notable experts involved in nuclear medicine and oncology across multiple French institutions.