68Ga-PSMA-11 PET/CT for Initial Staging of Unfavorable Intermediate-Risk and High-Risk Prostate Cancer Predicts Overall Survival: An IAEA Multicenter Study.

Although multiple studies have demonstrated the accuracy of 68Ga-PSMA-11 PET/CT, its ability to predict survival outcomes and treatment response remains unclear. This study assessed the prognostic value of 68Ga-PSMA-11 PET/CT in staging unfavorable intermediate- or high-risk prostate cancer (PCa) in patients who are candidates for radical prostatectomy. Methods: This prospective multicenter trial supported by the International Atomic Energy Agency enrolled 775 patients across 11 countries with newly diagnosed, unfavorable intermediate- or high-risk PCa. Patients underwent 68Ga-PSMA-11 PET/CT, after which their disease was categorized as N0M0 (no involvement of local nodes and no metastases), N1M0 (pelvic lymph node involvement), or NxM1 (distant metastases). These findings were then compared with clinical follow-up data. Results: Biochemical recurrence rates were 35.4% (N0M0), 68.2% (N1M0), and 77.2% (NxM1). Two-year event-free survival rates were 56.6%, 43.9%, and 26.0% in patients with N0M0, N1M0, and NxM1 disease, respectively. Two-year overall survival rates were 99.3% in patients with N0M0 disease, 99.2% in those with N1M0 disease, and 86.8% in those with NxM1 disease (P < 0.001). 68Ga-PSMA-11 PET/CT status was the only significant prognostic factor for survival outcomes. Conclusion: 68Ga-PSMA-11 PET/CT is a robust and independent prognostic marker in patients with unfavorable intermediate- or high-risk PCa and may help tailor treatments and improve outcomes.