NCT03103152: PROVENT

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

Completed Phase 2/Phase 3 Results posted Last updated 28 March 2023

What this trial tests

Phase 2/Phase 3 trial testing High dose Aspirin & Vitamin D in Prostate Cancer in 104 participants. Completed in 31 March 2020.

Timeline

1 December 2016

Primary endpoint
31 March 2020

31 March 2020

Quick facts

Lead sponsor	Queen Mary University of London
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	104
Start date	1 December 2016
Primary completion	31 March 2020
Estimated completion	31 March 2020
Sites	7 locations across United Kingdom

Drugs / interventions tested

• High dose Aspirin & Vitamin D — full drug profile →
• High dose Aspirin, Vitamin D placebo — full drug profile →
• Low dose Aspirin , Vitamin D — full drug profile →
• Low dose Aspirin, Vitamin D placebo — full drug profile →
• Aspirin Placebo, Vitamin D — full drug profile →
• Aspirin placebo, Vitamin D placebo

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Queen Mary University of London

Who can join

Adults 16 to 100, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer-Associated Fibroblasts and Tumor-Associated Macrophages in Cancer and Cancer Immunotherapy.
   Raskov H, Orhan A, Gaggar S, Gögenur I. · · 2021 · cited 99× · PMID 34094963 · DOI 10.3389/fonc.2021.668731
2. A novel computational approach for drug repurposing using systems biology.
   Peyvandipour A, Saberian N, Shafi A, Donato M, et al · · 2018 · cited 72× · PMID 29534151 · DOI 10.1093/bioinformatics/bty133
3. Diet and lifestyle considerations for patients with prostate cancer.
   Zuniga KB, Chan JM, Ryan CJ, Kenfield SA. · · 2020 · cited 36× · PMID 31327752 · DOI 10.1016/j.urolonc.2019.06.018
4. Anti-Cancer Stem-Cell-Targeted Therapies in Prostate Cancer.
   Gogola S, Rejzer M, Bahmad HF, Alloush F, et al · · 2023 · cited 14× · PMID 36900412 · DOI 10.3390/cancers15051621
5. Evaluation of Different Formulations and Routes for the Delivery of the Ionizing Radiation Mitigator GS-Nitroxide (JP4-039).
   Epperly MW, Wipf P, Fisher R, Franicola D, et al · · 2018 · cited 12× · PMID 30150422 · DOI 10.21873/invivo.11341
6. Feasibility of aspirin and/or vitamin D3 for men with prostate cancer on active surveillance with Prolaris® testing.
   Dinneen E, Shaw GL, Kealy R, Alexandris P, et al · · 2022 · cited 7× · PMID 36267207 · DOI 10.1002/bco2.169
7. Exploring the Link Between Obligate Anaerobe-Related Dysbiosis and Prostate Cancer Development: A Pilot Study.
   Ladoukakis E, Oliver T, Wilks M, Lane EF, et al · · 2024 · cited 1× · PMID 39796699 · DOI 10.3390/cancers17010070