Abstract | PURPOSE: MATERIALS AND METHODS: RESULTS: The number of evaluable patients, that is those with 1 on study biopsy who were compliant, was 447. The cumulative risk of prostate cancer was decreased in patients on 20 mg toremifene compared with placebo (24.4% vs 31.2%, p <0.05). The annualized rate of prevention was 6.8 cancers per 100 men treated. In patients with no biopsy evidence of cancer at baseline and 6 months, the 12-month incidence of prostate cancer was decreased by 48.2% with 20 mg toremifene compared with placebo (9.1% vs 17.4%, p <0.05). The 20 mg dose was most effective but cumulative and 12-month incidences of prostate cancer were lower for each toremifene dose vs placebo with a cumulative risk of 29.2% and 28.1%, and a 12-month incidence of 14.3% and 13.0% for 40 and 60 mg, 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. CONCLUSIONS:
Toremifene decreased the incidence of prostate cancer by 1 year and had a tolerability profile comparable to that of placebo in a high risk population.
|
Authors | David Price, Barry Stein, Paul Sieber, Ronald Tutrone, James Bailen, Erik Goluboff, Daniel Burzon, David Bostwick, Mitchell Steiner |
Journal | The Journal of urology
(J Urol)
Vol. 176
Issue 3
Pg. 965-70; discussion 970-1
(Sep 2006)
ISSN: 0022-5347 [Print] United States |
PMID | 16890670
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antineoplastic Agents, Hormonal
- Toremifene
|
Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Double-Blind Method
- Humans
- Male
- Middle Aged
- Prostatic Intraepithelial Neoplasia
(prevention & control)
- Prostatic Neoplasms
(prevention & control)
- Toremifene
(therapeutic use)
|