Implementation and Real-World Outcomes of [177Lu]Lu-PSMA-617 for Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer: Following Public Reimbursement in Canada

[177Lu]Lu-PSMA-617 improves outcomes in patients with PSMA-positive metastatic Androgen Pathway Modulation-Resistant prostate cancer (mAPMR) previously treated with androgen deprivation therapy, androgen receptor pathway inhibitors and taxane chemotherapy; however, Canadian real-world data following public reimbursement remain limited. We evaluated the implementation and outcomes of a multidisciplinary theranostic program and the initial real-world experience with [177Lu]Lu-PSMA-617 at Princess Margaret Cancer Centre, University Health Network. In total, 77 consecutive patients with mAPMR treated between December 2024 and May 2026 were retrospectively reviewed. Median age was 72 years, 22% had visceral metastases, and median baseline PSA was 146 µg/L. Patients received a median of four treatment cycles. Median follow-up was 7.2 months. PSA, PSA50 response, and radiographic response rates were 66%, 40%, and 19%, respectively. Median radiographic progression-free survival was 6.7 months (95% CI 4.7–9.1), and median overall survival was 12.3 months (95% CI 9.8—not reached). Grade 3–4 adverse events occurred in 16% of patients, and treatment discontinuation rate due to toxicity was only 1%. Despite less favourable baseline characteristics than the pivotal VISION trial, [177Lu]Lu-PSMA-617 demonstrated clinically meaningful activity and a manageable safety profile. These findings support the feasibility and effectiveness of delivering PSMA-targeted radioligand therapy within a publicly funded healthcare system.