Scholarlink

Background <p>The ProsD trial aimed to determine if oral vitamin D supplementation could prevent prostate cancer (<b>PC</b>) progression in men on active surveillance (<b>AS</b>).</p> Methods <p>ProsD is a phase-II double-blinded randomized trial of newly diagnosed, low-intermediate risk PC cases, aged between 50 and 80 years and on AS. The intervention was a monthly oral dose of cholecalciferol (50,000IU; Vitamin D) or placebo. Primary and secondary endpoints were active therapy-free (<b>ATFS</b>) and progression-free (<b>PFS</b>) survival, respectively. Blood samples were analysed for vitamin D metabolites and cytokinesis-block micronucleus cytome (CBMN) markers for lymphocytic genome damage.</p> Results <p>There were 123 randomised participants (81 vitamin D and 42 placebo) included in this analysis. Mean (SD) for age was 66.5 (6.6) years and for 25(OH)D levels were 72.0 (19.9) and 66.4 (18.4) nmol/L at baseline (<i>p </i>= 0.1), and 91.9 (19.9) and 60.4 (24.4) nmol/L at 24 months, in the vitamin D and placebo arms respectively. There were no appreciable differences in ATFS (p<sub>log-rank</sub> = 0.44), PFS (p p<sub>log-rank</sub> = 0.60) and occurrence of adverse events, in each trial arm. There were declines in some of the lymphocytic CBMN markers in the vitamin D arm.</p> Conclusion <p>Vitamin D supplementation did not prevent PC progression, although reduced prevalence of CBMN markers may indicate a benefit of vitamin D supplementation.</p> Trial registration <p>Australia New Zealand Clinical Trials Registry (ACTRN12616001707459).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

High-dose vitamin D supplementation and prostate cancer progression: a phase II randomised trial in localised prostate cancer cases with intermediate risk of progression (ProsD)

  • 期刊论文

  • 发表日期：

    2025年12月21日

查看全文
  • Visalini Nair-Shalliker,
  • David P. Smith,
  • Val Gebski,
  • Manish I. Patel,
  • Mark Frydenberg,
  • John Yaxley,
  • Robert ‘Frank’ Gardiner,
  • David Espinoza,
  • Michael G. Kimlin,
  • Varinderpal Dhillon,
  • Wayne Leifert,
  • David Gillatt,
  • Henry Woo,
  • Krishan Rasiah,
  • Nader Awad,
  • James Symons,
  • Jadon K. Wells,
  • Hilda A. Pickett,
  • Michael Fenech,
  • Paul H. Anderson,
  • Bruce K. Armstrong,
  • Howard Gurney

摘要

Background

The ProsD trial aimed to determine if oral vitamin D supplementation could prevent prostate cancer (PC) progression in men on active surveillance (AS).

Methods

ProsD is a phase-II double-blinded randomized trial of newly diagnosed, low-intermediate risk PC cases, aged between 50 and 80 years and on AS. The intervention was a monthly oral dose of cholecalciferol (50,000IU; Vitamin D) or placebo. Primary and secondary endpoints were active therapy-free (ATFS) and progression-free (PFS) survival, respectively. Blood samples were analysed for vitamin D metabolites and cytokinesis-block micronucleus cytome (CBMN) markers for lymphocytic genome damage.

Results

There were 123 randomised participants (81 vitamin D and 42 placebo) included in this analysis. Mean (SD) for age was 66.5 (6.6) years and for 25(OH)D levels were 72.0 (19.9) and 66.4 (18.4) nmol/L at baseline (p = 0.1), and 91.9 (19.9) and 60.4 (24.4) nmol/L at 24 months, in the vitamin D and placebo arms respectively. There were no appreciable differences in ATFS (plog-rank = 0.44), PFS (p plog-rank = 0.60) and occurrence of adverse events, in each trial arm. There were declines in some of the lymphocytic CBMN markers in the vitamin D arm.

Conclusion

Vitamin D supplementation did not prevent PC progression, although reduced prevalence of CBMN markers may indicate a benefit of vitamin D supplementation.

Trial registration

Australia New Zealand Clinical Trials Registry (ACTRN12616001707459).