Prostate cancer drug decreases incidence by 1 year in high-risk group

October 19, 2006

Treatment with the investigational agent toremifene citrate (Acapodene) decreased the incidence of prostate cancer by 1 year in patients with high-grade prostatic intraepithelial neoplasia, according to a study published recently in the Journal of Urology (2006; 176:965-71).

Treatment with the investigational agent toremifene citrate (Acapodene) decreased the incidence of prostate cancer by 1 year in patients with high-grade prostatic intraepithelial neoplasia, according to a study published recently in the Journal of Urology (2006; 176:965-71).

A total of 514 patients with no evidence of prostate cancer on screening biopsy were randomized to 20-, 40-, or 60-mg does of toremifene or placebo daily for 12 months. Patients underwent re-biopsy at 6 and 12 months.

The cumulative risk of prostate cancer was decreased in patients on toremifene, 20 mg, compared with placebo (24.4% vs. 31.2%, p<.05). In patients with no biopsy evidence of cancer at baseline and at 6 months, the 12-month incidence of prostate cancer was decreased by 48.2% with toremifene, 20 mg, compared with placebo (9.1% vs. 17.4%, p<.05).

The 20-mg dose was most effective, but cumulative and 12-month incidences of prostate cancer were lower for each toremifene dose versus placebo, with a cumulative risk of 29.2% and 28.1%, and a 12-month incidence of 14.3% and 13% for the 40 mg and 60 mg doses, respectively. Gleason scores were similar across treatments.

The overall incidence of drug-related and serious adverse events did not differ between any of the toremifene groups and the placebo group, according to the study’s authors, led by David Price, MD, of Regional Urology LLC, Shreveport, LA.