Determining the Likelihood of Prostate Cancer Detection in Men Taking Dutasteride When Biopsy is Performed 'for Cause'.
Purpose: Determining the likelihood of prostate cancer detection in men taking dutasteride
when biopsy is performed 'for cause'.
Population: The population of interest is the REDUCE Biopsied population, that is, all
subjects in the Efficacy population who have at least one post-baseline biopsy reviewed by
the Central Pathology Laboratory.
Analyses: Initial interest will be focused on data from the Year 1-2 time period, to avoid
the potential effect of the cancer diagnoses from the Year 2 scheduled biopsies on the
assessments utilized in the "for cause" definitions. Only PSA data from Years 1-2 and
baseline will be utilized in the computation of the various PSA metrics, and only Central
Pathology results from Years 1-2 will be utilized to establish post-baseline diagnoses. PSA
values on or within 42 days after date of biopsy will be excluded from the analyses, to
avoid potential effects of biopsy on the PSA value.
For each of the 4 groups of subjects, the following will be summarized: number of subjects
meeting the corresponding criteria, number and % of subjects diagnosed with prostate cancer,
number and % of such subjects diagnosed with Gleason 7-10, and number and % of subjects
diagnosed with either prostate cancer, HGPIN or ASAP. Summaries of the numbers of subjects
meeting each of the specific criteria for group 1 (a through e) and Group 2 (a through h)
will be provided.
In addition, summaries investigating the effect of baseline variables (such as age, family
history of prostate cancer, prostate volume, percent free PSA, number of cores at the entry
biopsy) on the occurrence of prostate cancer diagnoses and Gleason 7-10 diagnoses may be
Time Perspective: Retrospective
Cancer detection risk among the groups in the "for cause" context
Determination of differences in cancer detection risk rate depending on cause vs no cause in that group compared to placebo
Stephen Jones, MD
The Cleveland Clinic
United States: Institutional Review Board
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