For Cause Prostate Biopsy in REDUCE Population Trial

The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Results showed a relative risk reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer. For REDUCE, biopsies were defined as "protocol biopsy" if performed at certain timeframes, and "for cause" if outside these predetermined timeframes. The investigators propose a post hoc analysis that would allow them to include biopsies that really justified a clinical indication, but were excluded from "for cause" analysis based on occurring at either the 2 or 4 year timeframes. Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as: Group 1--dutasteride group biopsied "for cause" using several definitions: biopsy of patients who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a PSA rise\>0.2 ng/ml or who had a new abnormal DRE or had a free PSA\<12% . The investigators define these as such because this would reasonably instigate biopsy if the clinician had a patient with this scenario in the non-study setting. Group 2--placebo group biopsied "for cause" using several definitions, regardless of timeframe but reported at each year of the study and aggregate, with the aggregate number being the primary outcome. Thus the investigators would request results of biopsy of patients who received placebo To establish differences in biopsy positive rates the groups as per each definition listed, to determine if dutasteride decreased the likelihood of "for cause" biopsy compared to "not for cause" biopsy, and if there is a difference in cancer detection risk rate depending on cause vs. no cause in that group compared to placebo.

Sex

Male

Minimum age

50 Years

Maximum age

75 Years

Inclusion Criteria:

Group 1-subjects in the dutasteride treatment group who meet the following sets of criteria:

* A rise in PSA from nadir at any time post-nadir
* PSA change from baseline \>0.2 ng/ml at any time post-baseline
* Abnormal DRE at any time post-baseline
* Free PSA\<12% at any time post-baseline
* At least one of the above 4 criteria.

Group 2-subjects in the placebo treatment group who meet the following sets of criteria:

* Change from baseline PSA between 0.0 and 0.35 (ie, 0.0 ≤ change from baseline PSA \< 0.35) at any time post-baseline. Note that in REDUCE PSA was recorded to the nearest 0.1.
* Abnormal DRE at any time post-baseline
* Change from baseline PSA ≥ 0.35 at any time post-baseline
* Change from baseline PSA ≥ 0.75 at any time post-baseline
* PSA ≥ 2.5 at any time post-baseline
* PSA ≥ 4.0 at any time post-baseline
* Percent Free PSA \< 12% at any time post-baseline
* At least one of the above 7 criteria.

• RESULTAndriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, Pettaway CA, Tammela TL, Teloken C, Tindall DJ, Somerville MC, Wilson TH, Fowler IL, Rittmaster RS; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127. PMID 20357281