Abstract | PURPOSE: PATIENTS AND METHODS: One thousand five hundred ninety men with HGPIN, or HGPIN and atypia, and no PCa on prostate biopsy were randomly assigned 1:1 to receive toremifene citrate 20 mg or placebo in a 3-year phase III, double-blind, multicenter trial. Men underwent annual biopsy until cancer detection or study end. Efficacy analysis was performed in 1,467 men who underwent at least one on-study biopsy. Baseline risk factors were evaluated to determine influence on cancer detection. RESULTS:
Cancer was detected in 34.7% and 32.3% of men in the placebo and treatment groups, respectively, with no observed difference (P = .39, log-rank test) in PCa-free survival. The 3-year Kaplan-Meier PCa-free survival estimate was 54.9% (99% CI, 43.3% to 66.5%) in the placebo group and 59.5% (99% CI, 48.1% to 70.9%) in the treatment group. Exploration of baseline risk factors demonstrated no subset in which a risk reduction was observed. In the placebo group, 17.9%, 12.9%, and 13.6% of men at risk at the beginning of years 1, 2, and 3, respectively, were diagnosed with PCa. CONCLUSION: Although toremifene 20 mg did not lower the PCa detection rate, men with isolated HGPIN have a high likelihood of eventual PCa diagnosis, demonstrating they are ideal candidates for inclusion in chemoprevention trials and require surveillance by periodic prostate biopsy.
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Authors | Samir S Taneja, Ronald Morton, Gary Barnette, Paul Sieber, Michael L Hancock, Mitchell Steiner |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 31
Issue 5
Pg. 523-9
(Feb 10 2013)
ISSN: 1527-7755 [Electronic] United States |
PMID | 23295793
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Hormonal
- Biomarkers, Tumor
- Selective Estrogen Receptor Modulators
- Toremifene
- Prostate-Specific Antigen
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Analysis of Variance
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Biomarkers, Tumor
(blood)
- Biopsy
- Disease Progression
- Disease-Free Survival
- Double-Blind Method
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Neoplasm Grading
- Population Surveillance
- Prospective Studies
- Prostate-Specific Antigen
(blood)
- Prostatic Hyperplasia
(complications)
- Prostatic Intraepithelial Neoplasia
(drug therapy, immunology, pathology)
- Prostatic Neoplasms
(diagnosis, etiology, immunology, pathology, prevention & control)
- Risk Assessment
- Risk Factors
- Selective Estrogen Receptor Modulators
(therapeutic use)
- Toremifene
(therapeutic use)
- Treatment Outcome
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