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

M. S. Stratton, M. E. Reid, G. Schwartzberg, F. E. Minter, B. K. Monroe, David S Alberts, J. R. Marshall, Frederick R Ahmann

Research output: Contribution to journalArticle

38 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)589-594
Number of pages6
JournalAnti-Cancer Drugs
Volume14
Issue number8
DOIs
StatePublished - Sep 2003

Fingerprint

Selenium
Prostatic Neoplasms
Biopsy
Prostate-Specific Antigen
Prostate
Medical History Taking
Yeasts
Placebos
Guideline Adherence
Phase III Clinical Trials
Random Allocation
Alkaline Phosphatase
Epidemiologic Studies
Body Mass Index
Smoking
Safety
Neoplasms

Keywords

  • Negative Biopsy Study
  • Prostate cancer
  • Selenium

ASJC Scopus subject areas

  • Pharmacology
  • Cancer Research
  • Oncology

Cite this

Selenium and prevention of prostate cancer in high-risk men : The Negative Biopsy Study. / Stratton, M. S.; Reid, M. E.; Schwartzberg, G.; Minter, F. E.; Monroe, B. K.; Alberts, David S; Marshall, J. R.; Ahmann, Frederick R.

In: Anti-Cancer Drugs, Vol. 14, No. 8, 09.2003, p. 589-594.

Research output: Contribution to journalArticle

Stratton, MS, Reid, ME, Schwartzberg, G, Minter, FE, Monroe, BK, Alberts, DS, Marshall, JR & Ahmann, FR 2003, 'Selenium and prevention of prostate cancer in high-risk men: The Negative Biopsy Study', Anti-Cancer Drugs, vol. 14, no. 8, pp. 589-594. https://doi.org/10.1097/00001813-200309000-00003
Stratton, M. S. ; Reid, M. E. ; Schwartzberg, G. ; Minter, F. E. ; Monroe, B. K. ; Alberts, David S ; Marshall, J. R. ; Ahmann, Frederick R. / Selenium and prevention of prostate cancer in high-risk men : The Negative Biopsy Study. In: Anti-Cancer Drugs. 2003 ; Vol. 14, No. 8. pp. 589-594.
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