NCT03103152

A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression

PROVENT: A Randomised, Double Blind, Placebo Controlled Feasibility Study to Examine the Clinical Effectiveness of Aspirin and/or Vitamin D3 to Prevent Disease Progression in Men on Active Surveillance for Prostate Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: Male
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the acceptability and feasibility of recruitment to a randomised chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate cancer.

Detailed description

The PROVENT study is a randomised, double blind, placebo controlled feasibility study to examine the clinical effectiveness of aspirin and/or Vitamin D3 to prevent disease progression in men on Active Surveillance for prostate cancer The main outcome measure of the trial is the rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer Secondary outcomes include the response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate, biochemical disease progression and histological disease progression after 12 months of therapy and finally toxicity and/or allergy to both aspirin and Vitamin D3.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	High dose Aspirin & Vitamin D	Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
DRUG	High dose Aspirin, Vitamin D placebo	Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
DRUG	Low dose Aspirin , Vitamin D	Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
DRUG	Low dose Aspirin, Vitamin D placebo	Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
DRUG	Aspirin Placebo, Vitamin D	Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
DRUG	Aspirin placebo, Vitamin D placebo	Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2017-04-06
• Last updated: 2023-03-29
• Results posted: 2023-03-29

Locations

7 sites across 1 country: United Kingdom