PURPOSE: The primary objective of the REDUCE Follow-up Study was to collect data on the occurrence of newly diagnosed prostate cancers for 2-years beyond the 4-year REDUCE study.
MATERIALS AND METHODS: The 4-year REDUCE study evaluated prostate cancer risk reduction in men taking dutasteride. This 2-year observational study followed men from REDUCE with a clinic visit shortly after study conclusion and up to 2 annual telephone calls, during which patient-reported data were collected regarding prostate cancer events, chronic medication use, PSA levels and SAEs. No study drug was provided and all biopsies during the 2-year follow-up were performed 'for-cause'. The primary objective was to collect data on the occurrence of new biopsy-detectable prostate cancers. Secondary endpoints included assessment of Gleason score and SAEs.
RESULTS: A total of 2,751 men enrolled, with similar numbers from both of the REDUCE former treatment groups (placebo and dutasteride). Few new prostate cancers were detected during the 2-year follow-up period in either former treatment group. A higher number of cancers were detected in the former dutasteride group, than in the former placebo group (14 vs 7 cases). No Gleason score 8-10 prostate cancers were detected in either former treatment group, based on central pathology review. No new safety issues were identified during the study.
CONCLUSIONS: Two years of follow-up of the REDUCE study cohort demonstrated a low rate of new prostate cancer diagnoses in the former placebo and dutasteride-treated groups. No new Gleason 8-10 cancers were detected.
Written by:
Grubb RL, Andriole GL, Somerville MC, Mahoney C, Manyak MJ, Castro R. Are you the author?
Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
Reference: J Urol. 2012 Sep 25. pii: S0022-5347(12)04995-6.
doi: 10.1016/j.juro.2012.09.099
PubMed Abstract
PMID: 23021996
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