Population
RECURRENCE
This study was a prospective, open-label, randomized, 2-armed crossover study conducted in 6 study centers in France. Men who were at least 18 y old, who were diagnosed with PCa, and who had prior definitive therapy were considered for enrollment. Eligible patients presented with suspected PCa recurrence, defined as 3 consecutive PSA increases or a PSA rise of greater than or equal to 2.0 ng/mL above the nadir after radiotherapy (external-beam radiation therapy or brachytherapy) or cryotherapy or a PSA rise of greater than or equal to 0.2 ng/mL after prostatectomy. The main exclusion criteria were participation in another therapeutic clinical trial within 5 d of enrollment in the present study and a life expectancy of less than 6 mo.The study protocol was approved by a national ethics committee certified by the French Ministry of Health (Institutional Review Board: IORG0009855). All patients gave written informed consent before randomization.