Selenium and prevention of prostate cancer in high-risk men: the Negative Biopsy Study
作者:
M. S. Stratton,
M. E. Reid,
G. Schwartzberg,
F. E. Minter,
B. K. Monroe,
D. S. Alberts,
J. R. Marshall,
F. R. Ahmann,
期刊:
Anti-Cancer Drugs
(OVID Available online 2003)
卷期:
Volume 14,
issue 8
页码: 589-594
ISSN:0959-4973
年代: 2003
出版商: OVID
关键词: Negative Biopsy Study;prostate cancer;selenium
数据来源: OVID
摘要:
Epidemiological and clinical studies suggesting a significant inverse relationship between intake of dietary selenium and overall cancer risk have led to initiation of a randomized, placebo-controlled, phase III clinical trial testing the safety and efficacy of selenized yeast as a chemopreventive agent for prostate cancer. Participants eligible for the ‘Negative Biopsy Study’, which was initiated in August 1999, are men considered to be at high risk for prostate cancer because of at least one negative sextant prostate biopsy, which was clinically indicated within 1 year of enrollment to the study. After a 30-day run-in period to ensure protocol compliance, participants are randomized to receive either 200 or 400 μg selenized yeast or matched placebo once daily. Primary study endpoints include development of prostate cancer and prostate-specific antigen (PSA) velocity. Secondary biochemical endpoints include change in chromagranin A and alkaline phosphatase. As of 1 June 2003, 514 eligible participants had been enrolled. Randomization schema was effective for selected parameters including age, body mass index, smoking status, baseline PSA and baseline plasma selenium level. Various data, including medical history, family history, and urological symptoms and specimens (including blood and subsequent prostate biopsy samples) had been collected at baseline, and throughout both the intervention and follow-up stages of the protocol. The goal for accrual is 700 evaluable participants.
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