Prostate Cancer Vitamin D Clinical Trial
A phase II randomised controlled trial of vitamin D in localised prostate cancer cases with intermediate risk of progression (ProsD).
Macquarie University
120 participants
May 3, 2017
Interventional
Conditions
Summary
The primary purpose of this trial is to evaluate the efficacy of vitamin D supplementation for the prevention of progression in men with prostate cancer who have an immediate risk of progression. Who is it for? Men are eligible to participate in this trial if they are aged 50 to <80 and have been diagnosed with localised prostate cancer with intermediate risk of progression, for which they have chosen to go on active surveillance. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either vitamin D tablets, or to receive inactive sham tablets. Tablets in both groups will be taken orally, once per month, for two years. Participants will be followed up at the end of this period to assess for incidence of disease progression and commencement of active therapy. It is hoped that the findings from this trial will provide information on whether vitamin D supplementation is effective for preventing disease progression in men with prostate cancer.
Eligibility
Inclusion Criteria7
- Diagnosed within the last 6 months
- Men who were previously diagnosed with low-risk disease and whose disease have recently been upgraded (in the past 6 months) to fit our eligibility criteria, will also be eligible to participate in our study.
- Had an mpMRI (centrally reviewed, not limited to any PIRADS score) and:
- Gleason score = 7 (e.g. Gleason grade 3+4) or
- or more 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)
Exclusion Criteria15
- Men with low risk disease:
- No visible tumour on MRI or
- Gleason score 6 or less and
- PSA<10ng/mL and
- Clinical stage <T2
- Men with high risk disease:
- Gleason score 8 or more or
- PSA>20ng/mL or
- Clinical stage T3 or T4 or N/M >0.
- Daily Vitamin D supplementation more than 50% of RDI (more than 300IU/day).
- Hyperparathyroidism, hypercalcaemia, or osteomalacia.
- With a glomerular filtration rate (GFR) below 30 which will include those with severe loss of kidney function, and that is, to exclude anyone with Stage 4 or Stage 5 kidney disease 4. *History of renal calculi.
- Taking orlistat, cholesterol-lowering drug called bile acid sequestrants such as cholestyramine and cholestipol or other drugs known to reduce vitamin D absorption.
- Those with gastrointestinal abnormalities that may affect nutrient absorption such as, those who are unable to swallow oral medication, those who have clinically diagnosed malabsorption syndrome with evidence of malabsorption, or those who have had prior surgical procedure affecting absorption.
- We will also exclude those unable to comprehend study information and its requirements for intellectual reasons, or if they do not have sufficient English proficiency.
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Interventions
Men in the intervention arm will take one vitamin D tablet orally (50,000IU), every month, for 24 months. To monitor adherence, each participant will be sent a reminder SMS and email reminding them to take their monthly tablet, when it is due. Each man will be followed up one week later by telephone to ensure compliance and check his well-being.
Locations(7)
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ACTRN12616001707459