A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression
NCT ID: NCT03103152
Last Updated: 2023-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
104 participants
INTERVENTIONAL
2016-12-31
2020-03-31
Brief Summary
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Detailed Description
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The main outcome measure of the trial is the rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer
Secondary outcomes include the response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate, biochemical disease progression and histological disease progression after 12 months of therapy and finally toxicity and/or allergy to both aspirin and Vitamin D3.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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High dose Aspirin & Vitamin D
Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
High dose Aspirin & Vitamin D
Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
High dose Aspirin, Vitamin D placebo
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
High dose Aspirin, Vitamin D placebo
Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Aspirin placebo, Vitamin D placebo
Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Low dose Aspirin , Vitamin D
Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day
Low dose Aspirin , Vitamin D
Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Low dose Aspirin, Vitamin D placebo
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Low dose Aspirin, Vitamin D placebo
Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
Aspirin Placebo, Vitamin D
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Low dose Aspirin , Vitamin D
Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin Placebo, Vitamin D
Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin placebo, Vitamin D placebo
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Aspirin placebo, Vitamin D placebo
Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Interventions
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High dose Aspirin & Vitamin D
Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
High dose Aspirin, Vitamin D placebo
Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Low dose Aspirin , Vitamin D
Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Low dose Aspirin, Vitamin D placebo
Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
Aspirin Placebo, Vitamin D
Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin placebo, Vitamin D placebo
Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical and radiological stage \<T3
* Serum Prostate Specific Antigen (PSA) ≤15.0 ng/ml
* Less than 10mm of cancer in a single core
Exclusion Criteria
2. Currently enrolled, or has been a participant within the last 30 days, in any other investigational drug or device study.
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 \>400IU Vitamin D 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 ( glucose-6-phosphate dehydrogenase) deficiency
17. Pre-existing macular degeneration
18. All contraindications to aspirin and Vitamin D3 (e.g. Sarcoidosis), including concomitant therapy with any medication that may interact with aspirin or Vitamin D3 (see section 4.10)
19. Tuberculosis
20. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)
16 Years
100 Years
MALE
No
Sponsors
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Barts and the London School of Medicine and Dentistry
OTHER
Cancer Research UK
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Greg Shaw, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary London
Jack Cuzick, PhD
Role: STUDY_DIRECTOR
Queen Mary London
Locations
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Darent Valley Hospital
Dartford, , United Kingdom
University Hospital of Wales
London, , United Kingdom
University Hospital UHCW NHS Trust
London, , United Kingdom
St Bartholomews Hospital London, Bart's and the London school of Medicine
London, , United Kingdom
University College Hospital London
London, , United Kingdom
Homerton Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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isrctn91422391
Identifier Type: -
Identifier Source: org_study_id
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