Patients (n) | Age (years) | PSA (ng/L) | Follow-Up (years) | Relative Risk of Prostate Cancer* | Absolute Risk of Prostate Cancer* | Absolute Risk of High-Grade Prostate Cancer* | Risk of Diabetes | |
---|---|---|---|---|---|---|---|---|
PCPT | 18,883 | >55 | ≤3 | 7 | ↓25% | ↓6% | ↑0.6% | n/a |
REDUCE | 8,231 | 55–75 | 2.5–10 | 4 | ↓23% | ↓5% | 0% to ↑0.5%† | n/a |
SELECT | 35,533 | >50 | ≤4 | 5.4 | ↑Trend with vitamin E | ↑Trend with vitamin E | No known effect | ↑Trend with selenium |
↵* Compared with placebo.
↵† Original publication did not demonstrate increased risk of high-grade cancer; however, the Food and Drug Administration mandated re-analysis of biopsy specimen based on modified Gleason score suggesting a 0.5% increase of high-grade prostate cancer in the dutasteride arm.
PSA, prostate-specific antigen.