With reference to the PLESS trial, which of the following is NOT TRUE?A. Inclusion criteria included moderate-tosevere LUTS
This was a double-blind, randomised, placebo-controlled trial, where 3040 men with moderateto-severe urinary symptoms and enlarged prostate glands were treated daily with 5 mg of finasteride or placebo for four years. They were assessed with symptom scores, urinary flow rates, and the occurrence of outcome events every four months. Prostate volume was measured in a subgroup of the men. During the four-year study period, 10% in the placebo group and 5% in the finasteride group underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55%). Acute urinary retention developed in 7% in the placebo group and in 3% in the finasteride group (reduction in risk with finasteride, 57%). The mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group. Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (McConnell et al., 1998).
It was the Prostate Cancer Prevention Trial (PCPT) that reported that 7 years of administration of finasteride reduced the risk of prostate cancer by 25% but with an apparent increased risk of high disease (Thompson et al., 2003).