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A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression (PROVENT)

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ClinicalTrials.gov Identifier: NCT03103152
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Barts and the London School of Medicine and Dentistry
Cancer Research UK
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:
To demonstrate the acceptability and feasibility of recruitment to a randomised chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: High dose Aspirin & Vitamin D Drug: High dose Aspirin, Vitamin D placebo Drug: Low dose Aspirin , Vitamin D Drug: Low dose Aspirin, Vitamin D placebo Drug: Aspirin Placebo, Vitamin D Drug: Aspirin placebo, Vitamin D placebo Phase 2 Phase 3

Detailed Description:

The PROVENT study is 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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : December 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose Aspirin & Vitamin D
Aspirin high dose (300mgs) daily & Vitamin D 4,000 IU (0.1mg) per day
Drug: High dose Aspirin & Vitamin D
Aspirin 1 x 300mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other Names:
  • Aspirin - acetylsalicylic acid
  • Vitamin D - Vigantol® Oil

Experimental: High dose Aspirin, Vitamin D placebo
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Drug: High dose Aspirin, Vitamin D placebo
Aspirin 1 x 300mg tablet daily & Vitamin D placebo (8 drops).
Other Names:
  • Aspirin - acetylsalicylic acid
  • Vitamin D placebo - Miglyol®812 Oil

Drug: Aspirin placebo, Vitamin D placebo
Aspirin 1 x 100mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other Names:
  • Aspirin Placebo, Vitamin D
  • Vitamin D placebo - Miglyol®812 Oil

Experimental: Low dose Aspirin , Vitamin D
Low dose aspirin (100mgs) daily & Vitamin D 4,000 IU (0.1mg) per day
Drug: Low dose Aspirin , Vitamin D
Aspirin 1 x 100mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other Names:
  • Aspirin - acetylsalicylic acid
  • Vitamin D - Vigantol® Oil

Placebo Comparator: Low dose Aspirin, Vitamin D placebo
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
Drug: Low dose Aspirin, Vitamin D placebo
Aspirin 1 x 100mg tablet daily & Vitamin D placebo 8 drops daily.
Other Names:
  • Aspirin - acetylsalicylic acid
  • Vitamin D placebo - Miglyol®812 Oil

Experimental: Aspirin Placebo, Vitamin D
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
Drug: Low dose Aspirin , Vitamin D
Aspirin 1 x 100mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other Names:
  • Aspirin - acetylsalicylic acid
  • Vitamin D - Vigantol® Oil

Drug: Aspirin Placebo, Vitamin D
Aspirin 1 x 300mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other Name: Vitamin D - Vigantol® Oil

Experimental: Aspirin placebo, Vitamin D placebo
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
Drug: Aspirin placebo, Vitamin D placebo
Aspirin 1 x 100mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other Names:
  • Aspirin Placebo, Vitamin D
  • Vitamin D placebo - Miglyol®812 Oil




Primary Outcome Measures :
  1. Rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer. Number accrued per month. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate. New lesion present or existing lesion + or - in size. [ Time Frame: 3 years ]
    Lesion on multi-parametric imaging where no MRI lesion at screening. An MRI scan shows a screening + or - in volume by > 33%, or an upgrading of MRI stage of disease to ≥3.

  2. Biochemical disease progression. 50% increase in serum Prostate Specific Antigen at 12 months from baseline. [ Time Frame: 12 months ]
  3. Histological disease progression. Increase in Gleason score or MCCL [ Time Frame: 3 years ]

    Histological disease progression will be defined as an increase in Gleason scores from: Gleason 3+3 to Gleason score 7 or higher Gleason 3+4 (score 7) to 4+3 (score 7) or Gleason 4+3 to a higher score

    Or a 50% increase in maximum cancer core length (MCCL)


  4. Toxicity and/or allergy to both aspirin and Vitamin D3; Symptoms of Aspirin or Vit D toxicity. [ Time Frame: 3 years ]

    Aspirin toxicity: Haemorrhagic stroke, anaphylaxis following administration, gastrointestinal bleeding requiring intervention (both medical and surgical)

    Vitamin D3 toxicity: Hypercalcaemia, Anaphylaxis




Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

      • 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 enrolment.

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 D3; or chronic use (defined as > 6 months continuous daily use) of either aspirin or replacement 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103152


Locations
United Kingdom
University Hospital of Wales
London, United Kingdom, CF14 4XW
University Hospital UHCW NHS Trust
London, United Kingdom, CV2 2DX
St Bartholomews Hospital London, Bart's and the London school of Medicine
London, United Kingdom, EC1A 7BE
University College Hospital London
London, United Kingdom, NW1 2B
Guy's Hospital
London, United Kingdom
Homerton Hospital
London, United Kingdom
Sponsors and Collaborators
Queen Mary University of London
Barts and the London School of Medicine and Dentistry
Cancer Research UK
Investigators
Principal Investigator: Thomas Powles, MD Queen Mary London
Study Director: Jack Cuzick, PhD Queen Mary London

Additional Information:
Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03103152     History of Changes
Other Study ID Numbers: isrctn91422391
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Queen Mary University of London:
Prostate Cancer
Active Surveillance
Chemo-prevention

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Aspirin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics