Phase 3
Completed N=104
A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression
Source: ClinicalTrials.gov NCT03103152 ↗Enrolled (actual)
104
Serious AEs
7.7%
Results posted
Mar 2023
Primary outcomePrimary: 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; 16; 19; 18 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
17; 16; 19; 18; 16; 18 | — |
| 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. |
1; 5; 5; 0; 3; 2 | — |
| SECONDARY Number of Participants With Biochemical (PSA) Disease Progression |
1; 2; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Histological Disease Progression |
2; 7; 5; 2; 3; 6 | — |
| SECONDARY Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D |
0; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
- Male subjects aged 16 years or over with an estimated life expectancy of more than three years
- Willing and able to provide written informed consent
- Corrected serum calcium ≤ 2.65mmol/l
- No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy)
- 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.
- 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 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
- 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)
Data sourced from ClinicalTrials.gov (NCT03103152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.