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

March 28, 2023 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dartford, United Kingdom, DA2 8DA
        • Darent Valley Hospital
      • London, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • London, United Kingdom, CV2 2DX
        • University Hospital UHCW NHS Trust
      • London, United Kingdom, EC1A 7BE
        • St Bartholomews Hospital London, Bart's and the London school of Medicine
      • London, United Kingdom, NW1 2B
        • University College Hospital London
      • London, United Kingdom
        • Homerton Hospital
      • Southampton, United Kingdom, S016 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

  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. All must be met for Inclusion:

      • Gleason score 6 or 7 (Gleason 3+3 or 3+4)
      • 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:

  1. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Vitamin D placebo - Miglyol®812 Oil
  • Aspirin Placebo, Vitamin D
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 Names:
  • 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:
  • Vitamin D placebo - Miglyol®812 Oil
  • Aspirin Placebo, Vitamin D

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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: 12 months
The proportion of eligible patients that join the trial over the 12-month trial recruitment period.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

Radiological progression was defined as 'development of a Prostate Imaging-Reporting and Data System (PI-RADS) 4/5 lesion (17) on mpMRI, where no lesion was identified before, 33% volume increase in the size of the lesion, or radiological upstaging to T3 or above based on local site reports.' Absence of these features represented radiologically stable disease.

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.
3 years
Number of Participants With Biochemical (PSA) Disease Progression
Time Frame: 12 months
50% increase in serum Prostate Specific Antigen at 12 months from baseline.
12 months
Number of Participants With Histological Disease Progression
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)
3 years
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Time Frame: 18 months + 30 days

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

Vitamin D3 toxicity: Hypercalcaemia, Anaphylaxis
18 months + 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Mary University of London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Research UK
Barts and the London School of Medicine and Dentistry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Greg Shaw, MD, Queen Mary London
  • Study Director: Jack Cuzick, PhD, Queen Mary London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • isrctn91422391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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