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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
104
Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Darent Valley Hospital
Dartford, United Kingdom
University Hospital of Wales
London, United Kingdom
University Hospital UHCW NHS Trust
London, United Kingdom
St Bartholomews Hospital London, Bart's and the London school of Medicine
London, United Kingdom
Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.
The proportion of eligible patients that join the trial over the 12-month trial recruitment period.
Time frame: 12 months
Response to Treatment as Determined by Serial Multi-parametric Magnetic Resonance Imaging (MRI) of the Prostate. New Lesion Present or Existing Lesion + or - in Size.
Radiological progression was defined as 'development of a Prostate Imaging-Reporting and Data System (PI-RADS) 4/5 lesion (17) on mpMRI, where no lesion was identified before, 33% volume increase in the size of the lesion, or radiological upstaging to T3 or above based on local site reports.' Absence of these features represented radiologically stable disease. Lesion on multi-parametric imaging where no MRI lesion at screening. An MRI scan shows a screening + or - in volume by \> 33%, or an upgrading of MRI stage of disease to ≥3.
Time frame: 3 years
Number of Participants With Biochemical (PSA) Disease Progression
50% increase in serum Prostate Specific Antigen at 12 months from baseline.
Time frame: 12 months
Number of Participants With Histological Disease Progression
Histological disease progression will be defined as an increase in Gleason scores from: Gleason 3+3 to Gleason score 7 or higher Gleason 3+4 (score 7) to 4+3 (score 7) or Gleason 4+3 to a higher score Or a 50% increase in maximum cancer core length (MCCL)
Time frame: 3 years
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Aspirin toxicity: Haemorrhagic stroke, anaphylaxis following administration, gastrointestinal bleeding requiring intervention (both medical and surgical) Vitamin D3 toxicity: Hypercalcaemia, Anaphylaxis
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Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
University College Hospital London
London, United Kingdom
Homerton Hospital
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Time frame: 18 months + 30 days