Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

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).

  • 2025-12-21
  • British journal of cancer 134(5)
    • 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

Study Design

Type
Randomized Controlled Trial (RCT)
Population
123 randomised participants (81 vitamin D and 42 placebo) newly diagnosed, low-intermediate risk PC cases, aged between 50 and 80 years and on active surveillance
Methods
Phase-II double-blinded randomized trial, monthly oral dose of cholecalciferol (50,000IU; Vitamin D) or placebo, blood samples analysed for vitamin D metabolites and cytokinesis-block micronucleus cytome (CBMN) markers
Blinding
Double-blind
Duration
24 months
Funding
Unclear

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).

Research Insights

Back to top