Comparison of 18F-PSMA-1007 and 18F-Choline PET/CT in prostate cancer patients with biochemical recurrence: a phase 3, prospective, multicenter, randomized study.

Abstract

This prospective, multicenter, open-label, randomized, crossover trial study was to evaluate the diagnostic performance of 18F-PSMA-1007 (PSMA) vs. 18F-Choline PET/CT (FCH) in prostate cancer (PCa) patients (pts) with biochemical recurrence (BCR). One hundred eighty-six pts, who have undergone primary definitive treatment for PCa with BCR, were recruited to this prospective study. All pts underwent one PSMA and one FCH PET/CT examination in randomized order within a time frame of 8 days and were followed up for at least 6 months (182 ± 10 days). Recurrence of PCa was observed in 176 out of 186 pts. The overall correct detection rate (DR) was 84% (95% CI 0.7967-0.8830) for PSMA and 69% (95% CI 0.6191-0.7489) for FCH, yielding a difference in proportion of 16% (P < 0.0001). PSMA had a sensitivity of 0.8464 and FCH 0.6857 with an odds ratio of 2.5259 (P < 0.0001), with statistically significant greater sensitivity of PSMA (ORs, 2.7877 and 2.1283 respectively) (P < 0.0001). PET/CT imaging led to a more accurate diagnosis in 166 (89.2%) pts, of which PSMA had contributed more than FCH in 91 (54.8%) of them. The DR for cutoff point PSA ≤ 1 ng/ml was higher for PSMA compared to FCH (61.8% vs. 39.5%). DR value of 51.6% for PSMA reached at PSA ≤ 0.3 ng/ml, while FCH reached that DR value with PSA ≤ 2.2 ng/ml. 18F-PSMA-1007 is more efficacious than 18F-Choline for the identification metastatic lesions both in patient and in regional level analysis in PCa patients with BCR.