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

Queen Mary University of London (UK)0 sites130 target enrollmentApril 16, 2014

Overview

2022 Results article in https://doi.org/10.1002/bco2.169 (added 08/07/2022)

Registry

who.int

Start Date

April 16, 2014

End Date

March 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

Queen Mary University of London (UK)

•Current inclusion criteria as of 10/12/2018:
•1\. Male subjects aged 16 years or over with an estimated life expectancy of more than three years
•2\. Willing and able to provide written informed consent
•3\. Corrected serum calcium \<2\.65 mmol/l
•4\. No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy)
•5\. All subjects must have had Magnetic Resonance Imaging (MRI) of the prostate with targeted biopsy of any lesions identified
•6\. Histologically confirmed prostate cancer\* following prostate biopsy (including at least 10 cores of prostate tissue) in men opting for Active Surveillance as their primary cancer therapy
•\*PROVENT Prostate Cancer Criteria for Inclusion:
•1\. Gleason score 6 or 7 (Gleason 3\+3 or 3\+4\)
•2\. Clinical and radiological stage 3\. Serum PSA of 15\.0 ng/ml or below

•Current exclusion criteria as of 10/12/2018:
•1\. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
•2\. Current enrolment in an investigational drug, device or other clinical research study or participation in such a study within 30 days of randomisation
•3\. Current daily use of aspirin or NSAIDs; or daily dietary supplements/medication containing more than 400 IU (10 micrograms per day)Vitamin D; or chronic use (defined as \> 6 months continuous daily use) of either aspirin or Vitamin D within two years of study enrolment
•4\. Current or previous use of 5\-alpha\-reductase inhibitors such as finasteride or dutasteride
•5\. Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
•6\. Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
•7\. Prior history of gastro\-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
•8\. Haemophilia or other bleeding diatheses
•9\. Prior history of renal stone disease