Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2019

A phase II randomised control trial of high dose vitamin D in localised low risk prostate cancer patients with intermediate risk of disease progression –ProsD (#338)

Visalini Nair-Shalliker 1 , Howard Gurney 2 , ProsD Investigators 2
  1. Cancer Council NSW, Woolloomolloo, NSW, Australia
  2. Department of Clinical Medicine, Macquarie University, Sydney, Australia

 

 

Background

Active surveillance (AS) for prostate cancer (PC) patients with low risk of PC death is an alternative to radical treatment. Vitamin D supplementation may prevent PC progression. There is no evidence for its long-term safety and efficacy, hence its use in the care of men with PC on AS needs assessment.  

 

Aim

Does vitamin D supplementation reduce the risk of PC progression in men with intermediate-risk disease, during the first two years of AS? 

 

Population

PC cases aged between 50 and 80 years will have a:

  • mpMRI (centrally reviewed, not limited to any PIRADS score) and
  • Gleason score=7 (e.g. Gleason grade 3+4) or
  • >2 positive biopsy core (which may include Gleason 6) or
  • Clinical stage T2 (which may include Gleason 6) or
  • PSA>10 ng/mL (which may include Gleason 6)

Men with a histologically proven prostate adenocarcinoma are randomised within 6 months of diagnosis.

Men whose disease were recently upgraded to fit our eligibility criteria are eligible to participate.

 

Study Design

A double-blinded, placebo-controlled randomized Phase II trial.

 

Intervention

Men in the intervention arm will receive an initial loading dose of vitamin D supplementation (500,000IU) followed by a monthly oral dose vitamin D supplementation (50,000IU), while controls will receive a monthly oral placebo, for 2 years (24 months).

 

Follow-up

Each participant will be followed up:

  • monthly to determine trial compliance.
  • 3 monthly for PSA levels and to monitor toxicity
  • at baseline 12- and 24- months to collect blood specimens, tissue biopsy and have a mpMRI scan

 

Primary Endpoint

Active therapy-free survival (ATFS) with no absolute requirements for conversion to ATFS.

 

Trial update

Recruitment commenced in April 2017 and aims to recruit 120 men. Of the 93 men invited, 76 have consented and enrolled.  Of these, 10 men have opted out to seek treatment.

 

ProsD is registered with ANZCTR (12616001707459).