Inclusion Criteria:
PART A
- Any subject who has participated in the REDUCE Study and meets one of the following
eligibility criteria is eligible for Part A, 2 Year Observational Follow-Up Study:
- Completed 4 years on Investigational Product through the REDUCE 4 Year study visit
(Visit 10) OR
- Was diagnosed with prostate cancer during the REDUCE study, discontinued
Investigational Product (IP) but participated in REDUCE Prostate Cancer Follow-Up
visits through the 4 Year study visit (Visit 10P) OR
- Withdrew from REDUCE study visit participation and IP (for any reasons) but
participated in REDUCE Follow-Up phone calls every 6 months through the 4 Year phone
call
Exclusion Criteria: PART A Subjects meeting the following criterion must not be enrolled
in Part A of the study
- Inability/unwillingness to participate in the Follow-Up Study phone calls.
Inclusion Criteria:
PART B
Subjects eligible for enrolment in Part B of the study must meet the following criteria:
- Any subject who was diagnosed with prostate cancer based on a prostate biopsy during
participation in the REDUCE Study, regardless of when their REDUCE study
participation ended.
Exclusion Criteria: PART B
- The exclusion criterion only applies to Part A, the 2 year Observational Follow-Up
Study. There are no exclusion criteria for Part B, Prostate Biopsy Tissue Study.