In the Prostate Cancer Prevention Trial, how many men over 62 years old with a normal PSA (≤4 ng/mL) and a normal rectal examination had prostate cancer on TRUS biopsy and how many men with cancer had Gleason ≥7 disease?a. 5% and 2.5%
The ‘Prostate Cancer Prevention Trial’ (PCPT) randomised 18,882 men to either finasteride or placebo. Eligibility criteria were prostate specific antigen (PSA) <3 ng/mL, age ≥55 years and a normal digital rectal examination (DRE). Participants underwent yearly PSA and DRE checks. A 6-core biopsy was performed if the PSA rose to 4 ng/mL. Overall a 25% relative risk and 4% absolute reduction in prostate cancer was seen, primarily tumours ≤Gleason 6. However, an absolute 15% increase in Gleason 7 and above tumours was seen in the treatment arm.