Study Subject Participation Status | Criteria Fulfill
Item
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:
boolean
C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Investigational New Drugs
Item
completed 4 years on investigational product through the reduce 4 year study visit (visit 10) or
boolean
C0013230 (UMLS CUI [1])
Prostate carcinoma | Investigational New Drugs Discontinued | Participation Follow-up
Item
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
boolean
C0600139 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
Participation Clinical Trial Visit Withdrawn | Investigational New Drugs Withdrawn | Participation Follow-up Telephone call
Item
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
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1512346 (UMLS CUI [1,3])
C0424092 (UMLS CUI [1,4])
C0013230 (UMLS CUI [2,1])
C0424092 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0302186 (UMLS CUI [3,3])
Exclusion Criteria Part Roman letter
Item
exclusion criteria: part a subjects meeting the following criterion must not be enrolled in part a of the study
boolean
C0680251 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Participation Follow-up Telephone call Unable | Participation Follow-up Telephone call Unwilling
Item
inability/unwillingness to participate in the follow-up study phone calls.
boolean
C0679823 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0302186 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0679823 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0302186 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Inclusion criteria Part Roman letter
Item
inclusion criteria: part b
boolean
C1512693 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Criteria Fulfill
Item
subjects eligible for enrolment in part b of the study must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prostate carcinoma Biopsy of prostate
Item
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.
boolean
C0600139 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
Exclusion Criteria Part Roman letter
Item
exclusion criteria: part b
boolean
C0680251 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Unspecified
Item
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.
boolean
C0205370 (UMLS CUI [1])