Men family

  • Inclusion Criteria:

    Prostate cancer patients that fulfil the following criteria are eligible to take part in the PROVENT study

    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 ≤ 2.65mmol/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:

    • Gleason score 6 or 7
    • Clinical and radiological stage <T3
    • Serum PSA ≤15.0 ng/ml
    • Less than 10mm of cancer in a single core

    Patients must have undergone a multi-parametric MRI deemed assessable by the local radiologist, and any lesions seen must have undergone targeted biopsy (transrectal or transperineal) within 12 months of study registration.

  • Exclusion Criteria:

    Patients with any of the following conditions will not be able to take part in PROVENT study

    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 D3; or chronic use (defined as > 6 months continuous daily use) of either Aspirin or >400IU Vitamin D3 within two years of study enrolment
    4. Current or previous use of 5-α 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
    10. Chronic renal disease (≥stage 4)
    11. Known hypercalcaemia (corrected serum calcium >2.65 mmol/l) or untreated hyperparathyroidism
    12. Any bowel condition that would make repeat transrectal biopsy hazardous or difficult to perform e.g. recto-urethral fistula, or prior bowel surgery such as abdomino-perineal resection.
    13. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years
    14. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration
    15. Severe Asthma
    16. G6PD deficiency
    17. Pre-existing macular degeneration
    18. All contraindications to Aspirin and Vitamin D3, including concomitant therapy with any medication that may interact with Aspirin or Vitamin D3 (see section 4.10)
    19. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)

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