PROVENT
Research type
Research Study
Full title
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
IRAS ID
145427
Contact name
Thomas Powles
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2014-001784-13
ISRCTN Number
ISRCTN91422391
Duration of Study in the UK
3 years, 1 months, 0 days
Research summary
This is a feasibility study for a larger trial that will examine whether taking aspirin, with or without Vitamin D3, can prevent the progression of prostate cancer in men who have been diagnosed with the disease.
It will include men who are suitable for, and have chosen to follow, an active surveillance programme for their cancer. This feasibility study will establish whether there is enough interest and willingness to participate among the study population to justify a full study.
Patients will be seen at one of five centres, usually in the regular active surveillance outpatient clinic where they would normally be seen if they were not in the study. They will take either aspirin 100mg or 300mg or aspirin placebo with either vitamin D or vitamin D placebo daily for up to 18 months. Patients will undergo some additional blood and urine tests, but otherwise will have the same routine tests as other patients on an active surveillance programme for prostate cancer.
A positive outcome of this study, and the subsequent larger study, would result in fewer men requiring radical prostate cancer therapy with its associated side effects.
REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/2033
Date of REC Opinion
18 Nov 2014
REC opinion
Favourable Opinion