Table 1.

Summary of study procedures

1	Inclusion criteria	Exclusion criteria	Demographics, baseline disease features	ECOG score	BPI SF—EORTC QLQ-C30	Complete blood test PSA and testosterone	Baseline staging within 45 days from randomization
Baseline	x	x	x	x	x	x	x
Follow up visit (months 3,6,9,12)				x	x	x	*

^*Same radiological exams used at baseline will be repeated in case of suspected clinical or biochemical progression. Furthermore, in baseline evaluation as well as in case of disease progression, the use of additional diagnostic exams (such as magnetic resonance imaging, MRI) is allowed according to clinical judgement