Selenium and prevention of prostate cancer in high-risk men: the Negative Biopsy Study.

Abstract:

: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 microg 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.

journal_name

Anticancer Drugs

journal_title

Anti-cancer drugs

authors

Stratton MS,Reid ME,Schwartzberg G,Minter FE,Monroe BK,Alberts DS,Marshall JR,Ahmann FR

doi

10.1097/00001813-200309000-00003

subject

Has Abstract

pub_date

2003-09-01 00:00:00

pages

589-94

issue

8

eissn

0959-4973

issn

1473-5741

journal_volume

14

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
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