ELIGIBILITY CRITERIA - PROSTATE

PROSTATE COHORT INCLUSION CRITERIA

  1. Men with histologically confirmed, node negative, non-metastatic adenocarcinoma of the prostate (T1-3a, N0). See appendix X for TNM staging definitions.
  2. Have undergone curative treatment, either
    • a. Radical prostatectomy.
      b. Radical radiotherapy (external beam or brachytherapy).
      c. Salvage radiotherapy following a rise in PSA after radical prostatectomy.
  3. Intermediate or high risk according to D’Amico classification76 (prior to radical treatment, see table below).

    D’Amico Classification

    Risk classification

     

    Low

    §  PSA less than or equal to 10

    §  And Gleason score less than or equal to 6

    §  Or clinical stage T1-2a

    Intermediate

    §  PSA between 10 and 20

    §  Or Gleason score of 7

    §  Or clinical stage T2b

    High

    §  PSA more than 20

    §  Or Gleason score equal or larger than 8

    §  Or clinical stage T2c-3a


  4. WHO performance status 0, 1 or 2.
  5. Written informed consent.
    Depending on the curative treatment pathway, participants must additionally satisfy the following:
    (a) Prostatectomy patients
  6. Open, laparoscopic or robotic radical prostatectomy.
  7. Men treated with immediate adjuvant radiotherapy are eligible. Timing of trial registration in terms of the treatment pathway should be as described in section 4.2 of the protocol.
  8. Men receiving adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy), planned for a maximum duration of three years, are eligible. Treatment can be ongoing at the time of registration/randomisation to Add-Aspirin.
  9. Men randomised to any of the 3 arms of RADICALS Hormone Duration study (RADICALS-HD, ISRCTN 40814031) are eligible provided all other eligibility criteria are met.
    (b)  Radical radiotherapy patients.
  10. Men receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) planned for a maximum duration of three years are eligible, and this treatment may be ongoing at the time of registration in Add-Aspirin.
  11. Timing of registration in Add-Aspirin in terms of the treatment pathway should be as described in section 4.2 of the protocol.
    (c) Salvage radiotherapy patients (following rise in PSA after previous radical prostatectomy)
  12. Men treated with salvage radiotherapy following a rise in PSA are eligible. Timing of trial registration in terms of the treatment pathway should be as described in section 4.2 of the protocol.
  13. Men receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) planned for a maximum duration of three years are eligible, and this treatment may be ongoing at the time of registration in Add-Aspirin.
  14. Men randomised to any of the 3 arms of RADICALS Hormone Duration study (RADICALS-HD, ISRCTN 40814031) are eligible provided all other eligibility criteria are met.

PROSTATE COHORT EXCLUSION CRITERIA

  1. Biopsy proven or radiologically suspected nodal involvement or distant metastases from prostate cancer.
  2. Adjuvant hormone therapy planned for >3 years.
  3. Bilateral orchidectomy.
  4. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix IV for list of medications not permitted in the trial).
    a. Regular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks.
    b. Current NSAID use is defined as taking any NSAID for more than a week in the preceding month. If investigators feel that this definition may unfairly exclude a participant, this can be discussed with the MRC CTU and a case by case decision will be made.
  5. A past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs.
  6. Current use of anti-coagulants.
  7. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 
  8. Active or previous peptic ulceration or gastrointestinal bleeding, except where the cause of the bleeding has been surgically removed.
  9. Active or previous history of inflammatory bowel disease.
  10. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2.
  11. Previous invasive or non-invasive malignancy except:
    a. Prostate cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in PSA.
    b. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy.
    c. Low grade superficial bladder carcinoma where treatment consisted of endoscopic resection alone.
    d. Other cancers where the patient has been disease-free for ≥15 years.
  12. Any other physical condition which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, macular degeneration and patients with a high risk of mortality from another cause within the trial treatment period.
  13. Known G6PD deficiency.
  14. Known lactose intolerance.
  15. LFTs greater than 1.5x the upper limit of normal unless the participant has been discussed with the MRC CTU and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis.  
  16. Anticipated difficulties in complying with trial treatment or follow-up schedules.
  17. <16 years old in the UK or <18 years old in India.
  18. Participants in other treatment trials where this has not been agreed in advance by both trial teams.  Specific trials where a second randomisation has already been agreed with the relevant trial teams are indicated in the inclusion criteria. For all other trials, this should be discussed with the Trial Managers at the MRC CTU in the first instance.



The trial is being jointly funded by Cancer Research UK (grant number C471 /A15015, www.cancerresearchuk.org), the National Institute for Health Research Health Technology Assessment Programme (project number 12/01/38, www.nihr.ac.uk) and the MRC Clinical Trials Unit at UCL.
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