Prostate CancerPhase 2/3PROVENTNCT03103152
A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression
A Phase 2/3 study testing High dose Aspirin & Vitamin D and Low dose Aspirin , Vitamin D in people with Prostate Cancer, run by Queen Mary University of London at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High dose Aspirin & Vitamin D and Low dose Aspirin , Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Dec 2016to 31 Mar 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
- Currently enrolled, or has been a participant within the last 30 days, in any other investigational drug or device study.
- 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
- Current or previous use of 5-α reductase inhibitors such as finasteride or dutasteride
- Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
- Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
Show all 20Show fewer
- Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
- Haemophilia or other bleeding diatheses
- Prior history of renal stone disease
- Chronic renal disease (≥stage 4)
- Known hypercalcaemia (corrected serum calcium >2.65 mmol/l) or untreated hyperparathyroidism
- 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.
- Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years
- Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration
- Severe Asthma
- G6PD ( glucose-6-phosphate dehydrogenase) deficiency
- Pre-existing macular degeneration
- 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)
- Tuberculosis
- Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Darent Valley Hospital
Dartford, DA2 8DA
University Hospital of Wales
London, CF14 4XW
University Hospital UHCW NHS Trust
London, CV2 2DX
St Bartholomews Hospital London, Bart's and the London school of Medicine
London, EC1A 7BE
University College Hospital London
London, NW1 2B
Homerton Hospital
London
Southampton General Hospital
Southampton, S016 6YD
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- High dose Aspirin & Vitamin D, High dose Aspirin, Vitamin D placebo, Low dose Aspirin , Vitamin D, Low dose Aspirin, Vitamin D placebo, Aspirin Placebo, Vitamin D
- Keywords
- Prostate Cancer, Active Surveillance, Chemo-prevention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose Aspirin & Vitamin DDrug
Also called Aspirin - acetylsalicylic acid, Vitamin D - Vigantol® Oil
Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
High dose Aspirin, Vitamin D placeboDrug
Also called Aspirin - acetylsalicylic acid, Vitamin D placebo - Miglyol®812 Oil
Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).
Low dose Aspirin , Vitamin DDrug
Also called Aspirin - acetylsalicylic acid, Vitamin D - Vigantol® Oil
Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Low dose Aspirin, Vitamin D placeboDrug
Also called Aspirin - acetylsalicylic acid, Vitamin D placebo - Miglyol®812 Oil
Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.
Aspirin Placebo, Vitamin DDrug
Also called Vitamin D - Vigantol® Oil
Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
Aspirin placebo, Vitamin D placeboDrug
Also called Aspirin Placebo, Vitamin D, Vitamin D placebo - Miglyol®812 Oil
Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).
| Study group | Role | What they receive |
|---|---|---|
| High dose Aspirin & Vitamin D | Experimental | Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day Receives: Drug: High dose Aspirin & Vitamin D |
| High dose Aspirin, Vitamin D placebo | Experimental | high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil) Receives: Drug: High dose Aspirin, Vitamin D placebo; Drug: Aspirin placebo, Vitamin D placebo |
| Low dose Aspirin , Vitamin D | Experimental | Low dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day Receives: Drug: Low dose Aspirin , Vitamin D |
| Low dose Aspirin, Vitamin D placebo | Placebo comparator | Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil) Receives: Drug: Low dose Aspirin, Vitamin D placebo |
| Aspirin Placebo, Vitamin D | Experimental | Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil Receives: Drug: Low dose Aspirin , Vitamin D; Drug: Aspirin Placebo, Vitamin D |
| Aspirin placebo, Vitamin D placebo | Experimental | Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil Receives: Drug: Aspirin placebo, Vitamin D placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.
The proportion of eligible patients that join the trial over the 12-month trial recruitment period.
Measured: 12 months
Secondary outcomes (4)
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.
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.
Measured: 3 years
Number of Participants With Biochemical (PSA) Disease Progression
50% increase in serum Prostate Specific Antigen at 12 months from baseline.
Measured: 12 months
Number of Participants With Histological Disease Progression
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)
Measured: 3 years
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Aspirin toxicity: Haemorrhagic stroke, anaphylaxis following administration, gastrointestinal bleeding requiring intervention (both medical and surgical)
Vitamin D3 toxicity: Hypercalcaemia, Anaphylaxis
Measured: 18 months + 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startDec 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts and the London School of Medicine and Dentistry, Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Greg Shaw, MD, Principal investigator, Queen Mary LondonJack Cuzick, PhD, Study director, Queen Mary London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103152
- Sponsor's protocol ID
- isrctn91422391
- Acronym
- PROVENT
- Status last verified
- Mar 2020
- First submitted
- 21 Nov 2016
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03103152
- Acronym / sponsor ID
- PROVENT / isrctn91422391
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, Chemo-prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts and the London School of Medicine and Dentistry, Cancer Research UK
- Study start
- Dec 2016
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High dose Aspirin & Vitamin D | Experimental | Drug: High dose Aspirin & Vitamin DAspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day |
| High dose Aspirin, Vitamin D placebo | Experimental | Drug: High dose Aspirin, Vitamin D placebo, Drug: Aspirin placebo, Vitamin D placebohigh dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil) |
| Low dose Aspirin , Vitamin D | Experimental | Drug: Low dose Aspirin , Vitamin DLow dose aspirin (100mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day |
| Low dose Aspirin, Vitamin D placebo | Placebo comparator | Drug: Low dose Aspirin, Vitamin D placeboLow dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil) |
| Aspirin Placebo, Vitamin D | Experimental | Drug: Low dose Aspirin , Vitamin D, Drug: Aspirin Placebo, Vitamin DAspirin placebo and Vitamin D active ingredient - Vigantol® Oil |
| Aspirin placebo, Vitamin D placebo | Experimental | Drug: Aspirin placebo, Vitamin D placeboAspirin placebo and Vitamin D placebo - Miglyol®812 Oil |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
- Currently enrolled, or has been a participant within the last 30 days, in any other investigational drug or device study.
- 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
- Current or previous use of 5-α reductase inhibitors such as finasteride or dutasteride
- Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose Aspirin & Vitamin DAlso: Aspirin - acetylsalicylic acid, Vitamin D - Vigantol® OilAspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops). | Drug | High dose Aspirin & Vitamin D |
| High dose Aspirin, Vitamin D placeboAlso: Aspirin - acetylsalicylic acid, Vitamin D placebo - Miglyol®812 OilAspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops). | Drug | High dose Aspirin, Vitamin D placebo |
| Low dose Aspirin , Vitamin DAlso: Aspirin - acetylsalicylic acid, Vitamin D - Vigantol® OilAspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops). | Drug | Aspirin Placebo, Vitamin D, Low dose Aspirin , Vitamin D |
| Low dose Aspirin, Vitamin D placeboAlso: Aspirin - acetylsalicylic acid, Vitamin D placebo - Miglyol®812 OilAspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily. | Drug | Low dose Aspirin, Vitamin D placebo |
| Aspirin Placebo, Vitamin DAlso: Vitamin D - Vigantol® OilAspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops). | Drug | Aspirin Placebo, Vitamin D |
| Aspirin placebo, Vitamin D placeboAlso: Aspirin Placebo, Vitamin D, Vitamin D placebo - Miglyol®812 OilAspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops). | Drug | Aspirin placebo, Vitamin D placebo, High dose Aspirin, Vitamin D placebo |
Primary outcome
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.
4 secondary outcomes
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
Number of Participants With Biochemical (PSA) Disease Progression
Time frame: 12 months
Number of Participants With Histological Disease Progression
Time frame: 3 years
Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D
Time frame: 18 months + 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Shaw, MD principal investigator
Queen Mary London
Jack Cuzick, PhD study director
Queen Mary London
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing High dose Aspirin & Vitamin D and Low dose Aspirin , Vitamin D in people with Prostate Cancer, run by Queen Mary University of London at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.