Ga-PSMA-11 PET/CT staging predicts outcomes in unfavorable intermediate- and high-risk prostate cancer

This prospective multicenter trial across 11 countries enrolled 775 patients with newly diagnosed unfavorable intermediate- or high-risk prostate cancer who were candidates for radical prostatectomy. All patients underwent Ga-PSMA-11 PET/CT for initial staging, with no comparator group specified. The study examined the prognostic value of PET/CT staging categories rather than comparing PET/CT to alternative staging methods.

Results showed biochemical recurrence rates increased with more advanced disease on PET/CT: 35.4% for N0M0, 68.2% for N1M0, and 77.2% for NxM1. Two-year event-free survival was 56.6% for N0M0, 43.9% for N1M0, and 26.0% for NxM1. Most notably, two-year overall survival was 99.3% for N0M0, 99.2% for N1M0, but significantly lower at 86.8% for NxM1 (p < 0.001).

Safety and tolerability data were not reported. The study was supported by the International Atomic Energy Agency. Key limitations include the absence of a comparator group for PET/CT, no reported follow-up duration, and the observational nature that prevents causal inference. Ga-PSMA-11 PET/CT status was the only significant prognostic factor identified for survival outcomes, but this represents association rather than causation.

For clinical practice, these findings suggest Ga-PSMA-11 PET/CT may provide prognostic information that could inform treatment discussions, particularly for patients with distant metastases who showed substantially lower survival. However, the evidence does not establish that PET/CT staging improves outcomes compared to conventional staging approaches. The prognostic association requires validation in studies with direct comparisons to standard staging methods.