The 5 Alpha-Reductase Isozyme Family: A Review of Basic Biology and Their Role in Human Diseases
Table 4
Comparison between PCPT and REDUCE.
PCPT
REDUCE
Sponsor
South West Oncology Group
GalxoSmithKline
Duration
7 years
4 years
Risk of CaP in participants
lower
higher
No. of participants
18,882 randomized 9060 included in final analysis
8122 randomized
Age
≥55 years
50–75 years
Entry serum PSA
≤3.0 ng/mL
2.5–10 ng/mL
Baseline biopsies
No
Yes (6–12 cores) within 6 months prior to enrollment
Study-mandated biopsies
Year 7
Years 2 and 4
Study-mandated biopsy cores
≥6 (6 cores in nearly 80%)
10 (83% had at least 1 biopsy)
Overall relative risk reduction in CaP versus placebo
25%
23%
Incidence of Gleason sum ≥7 CaP
↑26% (6.4% in finasteride versus 5.1% in placebo),
Same (6.7% in dutasteride versus 6.8%: in placebo)
Incidence of Gleason sum ≥8 CaP
↑91% (2.1% in finasteride versus 1.1% in placebo),
Same over 4 years (0.9% in dutasteride versus 0.6% in placebo); however, in years 3-4, there were 12 GS ≥8 CaP in dutasteride group (0.5%) versus 1 in placebo group (<0.1%),