2. a rising serum PSA level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st measure within 3 months prior to recruitment); The first rising PSA (2nd measure) should be taken at least 14 days after the reference value. A confirmatory PSA measure (3rd measure) should be obtained at least 14 days after the 2nd measure and must be greater than the 2nd measure. Additionally, patient must have a serum PSA concentration of at least 2 ng/mL in addition to increasing PSA to be eligible. However, if the patient is clinically judged to have progressive disease irrespective of PSA (e.g. metastasis-related bone pain, clear increase in lesions evident on a bone scan and/or CT if available), documenting a minimum or rising PSA level would not be required.