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Phase 3 clinical trial investigating the effect of selenium supplementation in men at high-risk for prostate cancer.

ABSTRACT: This study was conducted to investigate the effect of Se supplementation on prostate cancer incidence in men at high risk for prostate cancer.A Phase 3 randomized, double-blind, placebo-controlled clinical trial was conducted in 699 men at high risk for prostate cancer (prostate specific antigen (PSA) >4?ng/ml and/or suspicious digital rectal examination and/or PSA velocity >0.75?ng/ml/year), but with a negative prostate biopsy. Participants were randomized to receive daily oral placebo (N?=?232), 200?µg selenium (N?=?234), or 400?µg selenium (N?=?233) as selenized yeast. They were followed every 6 months for up to 5 years. The time to diagnosis of prostate cancer was compared between treatment groups using the Cox proportional hazards model.Compared to placebo, the hazard ratios [95% confidence intervals] for risk of developing prostate cancer in the selenium 200?µg/day or the selenium 400?µg/day group were 0.94 [0.52, 1.7] and 0.90 [0.48, 1.7], respectively. PSA velocity in the selenium arms was not significantly different from that observed in the placebo group (P?=?0.18 and P?=?0.17, respectively).Selenium supplementation appeared to have no effect on the incidence of prostate cancer in men at high risk. In conjunction with results of other studies, these data indicate that selenium supplementation may not have a role in prostate cancer chemoprevention.

SUBMITTER: Algotar AM

PROVIDER: S-EPMC4086804 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Phase 3 clinical trial investigating the effect of selenium supplementation in men at high-risk for prostate cancer.

Algotar Amit M AM Stratton M Suzanne MS Ahmann Frederick R FR Ranger-Moore James J Nagle Raymond B RB Thompson Patricia A PA Slate Elizabeth E Hsu Chiu H CH Dalkin Bruce L BL Sindhwani Puneet P Holmes Michael A MA Tuckey John A JA Graham David L DL Parnes Howard L HL Clark Lawrence C LC Stratton Steven P SP

The Prostate 20120810 3

<h4>Purpose</h4>This study was conducted to investigate the effect of Se supplementation on prostate cancer incidence in men at high risk for prostate cancer.<h4>Methods</h4>A Phase 3 randomized, double-blind, placebo-controlled clinical trial was conducted in 699 men at high risk for prostate cancer (prostate specific antigen (PSA) >4 ng/ml and/or suspicious digital rectal examination and/or PSA velocity >0.75 ng/ml/year), but with a negative prostate biopsy. Participants were randomized to rec ...[more]

PMID: 22887343

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Project description:Objective:While controversial, observational and randomized clinical trial data implicate the micronutrient selenium (Se) in the development of type 2 diabetes (T2D). The aim of this study was to test the hypothesis that Se supplementation adversely affects pancreatic ?-cell function and insulin sensitivity. Research design and methods:In a subset of 400 individuals participating in a randomized, placebo-controlled trial of Se at 200?µg/day for colorectal adenomatous polyps, fasting plasma glucose and insulin were measured before randomization and within 6?months of completing intervention. Change in the homeostasis model assessment-? cell function (HOMA2-%?) and insulin sensitivity (HOMA2-%S) were compared between arms. A subgroup of 175 (79 Se and 96 placebo) participants underwent a modified oral glucose tolerance test (mOGTT) at the end of intervention and change in glucose values was assessed. Results:No statistically significant differences were observed for changes in HOMA2-%? or HOMA2-%S between those who received Se compared with placebo. After a mean of 2.9?years on study, mean HOMA2-%? values were 3.1±24.0?and 3.1±29.8?for the Se and placebo groups, respectively (p=0.99). For HOMA2-%S, the values were -0.5±223.2?and 80.9±1530.9?for the Se and placebo groups, respectively (p=1.00). Stratification by sex or age did not reveal any statistically significant effects on insulin sensitivity by treatment group. For mOGTT, mean baseline fasting blood glucose concentrations were significantly higher among participants in the placebo group compared with the Se group (96.6±14.6?and 92.3±12.0, respectively; p=0.04), a trend which remained through the 20?min assessment. Conclusions:These findings do not support a significant adverse effect of daily Se supplementation with 200?µg/day of selenized yeast on ?-cell function or insulin sensitivity as an explanation for previously reported associations between Se and T2D. Further clarification of longer term effects of Se is needed. Clinical trial registry:NIH Clinical Trials.gov number NCT00078897.

Project description:BackgroundObservational and preclinical studies show associations between selenium status, bone health, and physical function. Most adults in Europe have serum selenium below the optimum range. We hypothesised that selenium supplementation could reduce pro-resorptive actions of reactive oxygen species on osteoclasts and improve physical function.MethodsWe completed a 6-month randomised, double-blind, placebo-controlled trial. We recruited postmenopausal women older than 55 years with osteopenia or osteoporosis at the Northern General Hospital, Sheffield, UK. Participants were randomly assigned 1:1:1 to receive selenite 200 μg, 50 μg, or placebo orally once per day. Medication was supplied to the site blinded and numbered by a block randomisation sequence with a block size of 18, and participants were allocated medication in numerical order. All participants and study team were masked to treatment allocation. The primary endpoint was urine N-terminal cross-linking telopeptide of type I collagen (NTx, expressed as ratio to creatinine) at 26 weeks. Analysis included all randomly assigned participants who completed follow-up. Groups were compared with analysis of covariance with Hochberg testing. Secondary endpoints were other biochemical markers of bone turnover, bone mineral density, short physical performance battery, and grip strength. Mechanistic endpoints were glutathione peroxidase, highly sensitive C-reactive protein, and interleukin-6. This trial is registered with EU clinical trials, EudraCT 2016-002964-15, and ClinicalTrials.gov, NCT02832648, and is complete.Findings120 participants were recruited between Jan 23, 2017, and April 11, 2018, and randomly assigned to selenite 200 μg, 50 μg, or placebo (n=40 per group). 115 (96%) of 120 participants completed follow-up and were included in the primary analysis (200 μg [n=39], 50 μg [n=39], placebo [n=37]). Median follow-up was 25·0 weeks (IQR 24·7-26·0). In the 200 μg group, mean serum selenium increased from 78·8 (95% CI 73·5-84·2) to 105·7 μg/L (99·5-111·9). Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg. None of the secondary or mechanistic endpoint measurements differed between treatment groups at 26 weeks. Seven (6%) of 120 participants were withdrawn from treatment at week 13 due to abnormal thyroid-stimulating hormone concentrations (one in the 200 μg group, three in the 50 μg group, and three in the placebo group) and abnormal blood glucose (one in the 50 μg group). There were three serious adverse events: a non-ST elevation myocardial infarction at week 18 (in the 50 μg group), a diagnosis of bowel cancer after routine population screening at week 2 (in the placebo group), and a pulmonary embolus due to metastatic bowel cancer at week 4 (in the 200 μg group). All severe adverse events were judged by the principal investigator as unrelated to trial medication.InterpretationSelenium supplementation at these doses does not affect musculoskeletal health in postmenopausal women.FundingUK National Institute for Health Research Efficacy and Mechanism Evaluation programme.

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Phase 3 clinical trial investigating the effect of selenium supplementation in men at high-risk for prostate cancer.

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Phase 3 clinical trial investigating the effect of selenium supplementation in men at high-risk for prostate cancer.

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