Prostate Cancer Vitamin D Clinical Trial

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer progression; Vitamin D in preventing prostate cancer progression; Cancer - Prostate

• Registration Number: ACTRN12616001707459
• Lead Sponsor: Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-13
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 123

Inclusion Criteria

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
- 3 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 Criteria

Men with low risk disease:
*No visible tumour on MRI or
*Gleason score 6 or less and
*PSA<10ng/mL and
*Clinical stage
Men with high risk disease:
*Gleason score 8 or more or
*PSA>20ng/mL or
*Clinical stage T3 or T4 or N/M >0.

Other exclusion criteria are:
* 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified