Prostate cancer Cancer Prostate cancer
Conditions
Interventions
The principal method of randomisation will be by means of a purpose designed web-based application, developed by Barts CTU, which will be accessible to all relevant research staff. Staff will be train
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 <T3 3. Serum PSA of 15.0 ng/ml or below Less than 10 mm of cancer in a single core 7. 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 enrolment. Previous inclusion criteria: 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: 1. Gleason score 6 or 7 2. Clinical and radiological stage <T3 3. Serum PSA of 15.0 ng/ml or below Less than 10mm of cancer in a single core 7. 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 enrolment.
Exclusion criteria
Exclusion criteria: 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 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 D (e.g. Sarcoidosis), including concomitant therapy with any medication that may interact with aspirin or Vitamin D 19. Tuberculosis 20. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men) Previous exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer. This will be determined by screening logs and screening/randomisation case report forms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To report response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate - measured by performing repeat prostate MRI imaging 2. To report biochemical disease progression - measured by measuring serum PSA levels 3 monthly 3. To report histological disease progression - measured by measuring serum PSA levels 3 monthly 4. To report toxicity and/or allergy to both aspirin and Vitamin D. Toxicity will be evaluated 3 monthly using the Adverse Events Case Report Form and the patient diary cards on which patients will record side effects and adverse reactions 5. To evaluate an association between androgens and disease progression. Blood will be taken to measure serum androgen levels every 6 months - at baseline, 6 months, 12 months and 18 months 6. To evaluate markers of disease progression. Urinary markers of disease progression (PCA3 and TMPRSS2-ERG) will be evaluated at baseline and 12 months. Tissue will be collected from the baseline and 12 month prostate biopsies for Cell Cycle Progression scores. | — |
Countries
England, United Kingdom
Contacts
Public ContactRoseann Kealy
Outcome results
None listed