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

NCT03103152 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-03-29

Study results available
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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.

Conditions

Interventions

DRUG

High dose Aspirin & Vitamin D

Aspirin 1 x 300mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).

DRUG

High dose Aspirin, Vitamin D placebo

Aspirin 1 x 300mg tablet daily \& Vitamin D placebo (8 drops).

DRUG

Low dose Aspirin , Vitamin D

Aspirin 1 x 100mg tablet daily \& Vitamin D 4,000IU daily. (8 drops).

DRUG

Low dose Aspirin, Vitamin D placebo

Aspirin 1 x 100mg tablet daily \& Vitamin D placebo 8 drops daily.

DRUG

Aspirin Placebo, Vitamin D

Aspirin 1 x 300mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).

DRUG

Aspirin placebo, Vitamin D placebo

Aspirin 1 x 100mg placebo tablet daily \& Vitamin D 4,000IU daily. (8 drops).

Sponsors & Collaborators

  • Barts and the London School of Medicine and Dentistry

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Greg Shaw, MD · Queen Mary London

  • Jack Cuzick, PhD · Queen Mary London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103152 on ClinicalTrials.gov