Prostate Cancer
Conditions
Keywords
Prostate Cancer, Active Surveillance, Chemo-prevention
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.
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.
Interventions
DRUGHigh dose Aspirin & Vitamin D
Aspirin 1 x 300mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
DRUGHigh dose Aspirin, Vitamin D placebo
Aspirin 1 x 300mg tablet daily & Vitamin D placebo (8 drops).
DRUGLow dose Aspirin , Vitamin D
Aspirin 1 x 100mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
DRUGLow dose Aspirin, Vitamin D placebo
Aspirin 1 x 100mg tablet daily & Vitamin D placebo 8 drops daily.
DRUGAspirin Placebo, Vitamin D
Aspirin 1 x 300mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
DRUGAspirin placebo, Vitamin D placebo
Aspirin 1 x 100mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
Sponsors
Barts and the London School of Medicine and Dentistry
Cancer Research UK
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
16 Years to 100 Years
Healthy volunteers
No
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. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 12 months | The proportion of eligible patients that join the trial over the 12-month trial recruitment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Histological Disease Progression | 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) |
| 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. | 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. |
| Number of Participants With Biochemical (PSA) Disease Progression | 12 months | 50% increase in serum Prostate Specific Antigen at 12 months from baseline. |
| Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | 18 months + 30 days | Aspirin toxicity: Haemorrhagic stroke, anaphylaxis following administration, gastrointestinal bleeding requiring intervention (both medical and surgical) Vitamin D3 toxicity: Hypercalcaemia, Anaphylaxis |
Countries
United Kingdom
Participant flow
Recruitment details
12 months recruitment (December 2016 to Dec 2017). All recruitment took place in the hospital setting within active surveillance clinics.
Pre-assignment details
Helicobacter pylori (H. pylori) has been shown to be a causative factor in GI bleeding, so all participants were tested for this at randomisation as a precaution. Patients who tested positive were prescribed a course of proton pump inhibitors(PPIs) & antibiotics if they wished to continue on the study. GPs were informed. Serum calcium levels were also checked at baseline. Anyone with symptoms of hypercalcaemia was excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 17 |
| 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). | 16 |
| 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). | 19 |
| 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. | 18 |
| 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). | 16 |
| 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). | 18 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Inter-current illness | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 | 1 |
| Overall Study | Patient wishes to come off active surveillance | 2 | 0 | 1 | 1 | 1 | 3 |
| Overall Study | Physician Decision | 5 | 2 | 6 | 3 | 3 | 1 |
| Overall Study | Protocol Violation | 2 | 2 | 1 | 2 | 1 | 1 |
| Overall Study | Testicular pain | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Unacceptable side effects | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | 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 | Aspirin Placebo, Vitamin D Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 56 Years | 61 Years | 62 Years | 59.5 Years | 64 Years | 65.5 Years | 61 Years |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 19 Participants | 18 Participants | 16 Participants | 18 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 1 / 16 | 0 / 19 | 0 / 18 | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 5 / 17 | 9 / 16 | 6 / 19 | 4 / 18 | 7 / 16 | 11 / 18 |
| serious Total, serious adverse events | 2 / 17 | 2 / 16 | 2 / 19 | 1 / 18 | 1 / 16 | 0 / 18 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Number accrued by arm over the 12 month recruitment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Aspirin & Vitamin D | Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 17 Participants |
| High Dose Aspirin, Vitamin D Placebo | Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 16 Participants |
| Low Dose Aspirin , Vitamin D | Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 19 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 18 Participants |
| Aspirin Placebo, Vitamin D | Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 16 Participants |
| Aspirin Placebo, Vitamin D Placebo | Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month. | 18 Participants |
Secondary
Number of Participants With Biochemical (PSA) Disease Progression
50% increase in serum Prostate Specific Antigen at 12 months from baseline.
Time frame: 12 months
Population: Number of subjects analysed
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Dose Aspirin & Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Stable Disease | 9 Participants |
| High Dose Aspirin & Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Disease Regression | 1 Participants |
| High Dose Aspirin & Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Disease Progression | 2 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Stable Disease | 10 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Disease Regression | 2 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Disease Progression | 1 Participants |
| Low Dose Aspirin , Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Stable Disease | 10 Participants |
| Low Dose Aspirin , Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Disease Regression | 0 Participants |
| Low Dose Aspirin , Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Disease Progression | 1 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Stable Disease | 10 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Disease Regression | 0 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Disease Progression | 0 Participants |
| Aspirin Placebo, Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Stable Disease | 10 Participants |
| Aspirin Placebo, Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Disease Regression | 0 Participants |
| Aspirin Placebo, Vitamin D | Number of Participants With Biochemical (PSA) Disease Progression | Disease Progression | 2 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Disease Regression | 1 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Disease Progression | 1 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Participants With Biochemical (PSA) Disease Progression | Stable Disease | 13 Participants |
Secondary
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)
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Aspirin & Vitamin D | Number of Participants With Histological Disease Progression | 2 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Participants With Histological Disease Progression | 7 Participants |
| Low Dose Aspirin , Vitamin D | Number of Participants With Histological Disease Progression | 5 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Participants With Histological Disease Progression | 2 Participants |
| Aspirin Placebo, Vitamin D | Number of Participants With Histological Disease Progression | 3 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Participants With Histological Disease Progression | 6 Participants |
Secondary
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
Time frame: 18 months + 30 days
Population: Total intention to treat population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Dose Aspirin & Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | None of the above toxicities | 17 Participants |
| High Dose Aspirin & Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Hypercalcaemia | 0 Participants |
| High Dose Aspirin & Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Anaphylaxis either Vit D or Aspirin | 0 Participants |
| High Dose Aspirin & Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Rectal Bleeding | 0 Participants |
| High Dose Aspirin & Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Haemorrhagic Stroke | 0 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Rectal Bleeding | 0 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Haemorrhagic Stroke | 0 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | None of the above toxicities | 16 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Anaphylaxis either Vit D or Aspirin | 0 Participants |
| High Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Hypercalcaemia | 0 Participants |
| Low Dose Aspirin , Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Anaphylaxis either Vit D or Aspirin | 0 Participants |
| Low Dose Aspirin , Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Hypercalcaemia | 0 Participants |
| Low Dose Aspirin , Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Rectal Bleeding | 2 Participants |
| Low Dose Aspirin , Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Haemorrhagic Stroke | 0 Participants |
| Low Dose Aspirin , Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | None of the above toxicities | 17 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Anaphylaxis either Vit D or Aspirin | 0 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Rectal Bleeding | 0 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | None of the above toxicities | 18 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Hypercalcaemia | 0 Participants |
| Low Dose Aspirin, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Haemorrhagic Stroke | 0 Participants |
| Aspirin Placebo, Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Hypercalcaemia | 0 Participants |
| Aspirin Placebo, Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Haemorrhagic Stroke | 0 Participants |
| Aspirin Placebo, Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | None of the above toxicities | 16 Participants |
| Aspirin Placebo, Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Anaphylaxis either Vit D or Aspirin | 0 Participants |
| Aspirin Placebo, Vitamin D | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Rectal Bleeding | 0 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | None of the above toxicities | 17 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Anaphylaxis either Vit D or Aspirin | 0 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Haemorrhagic Stroke | 1 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Rectal Bleeding | 0 Participants |
| Aspirin Placebo, Vitamin D Placebo | Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D | Hypercalcaemia | 0 Participants |
Secondary
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.
Time frame: 3 years
Population: All participants with a baseline \& 12 mth MRI scan.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Dose Aspirin & Vitamin D | 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. | Stable Disease | 4 Participants |
| High Dose Aspirin & Vitamin D | 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. | Disease Regression | 1 Participants |
| High Dose Aspirin & Vitamin D | 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. | Disease Progression | 4 Participants |
| High Dose Aspirin, Vitamin D Placebo | 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. | Stable Disease | 3 Participants |
| High Dose Aspirin, Vitamin D Placebo | 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. | Disease Regression | 5 Participants |
| High Dose Aspirin, Vitamin D Placebo | 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. | Disease Progression | 0 Participants |
| Low Dose Aspirin , Vitamin D | 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. | Stable Disease | 2 Participants |
| Low Dose Aspirin , Vitamin D | 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. | Disease Regression | 5 Participants |
| Low Dose Aspirin , Vitamin D | 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. | Disease Progression | 1 Participants |
| Low Dose Aspirin, Vitamin D Placebo | 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. | Disease Regression | 0 Participants |
| Low Dose Aspirin, Vitamin D Placebo | 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. | Stable Disease | 4 Participants |
| Low Dose Aspirin, Vitamin D Placebo | 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. | Disease Progression | 1 Participants |
| Aspirin Placebo, Vitamin D | 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. | Disease Regression | 3 Participants |
| Aspirin Placebo, Vitamin D | 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. | Stable Disease | 6 Participants |
| Aspirin Placebo, Vitamin D | 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. | Disease Progression | 0 Participants |
| Aspirin Placebo, Vitamin D Placebo | 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. | Stable Disease | 6 Participants |
| Aspirin Placebo, Vitamin D Placebo | 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. | Disease Regression | 2 Participants |
| Aspirin Placebo, Vitamin D Placebo | 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. | Disease Progression | 0 Participants |