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

NCT03103152 | Completed Phase 2 Results DMC

• 1 other identifier: isrctn91422391
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 7

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Active Surveillance; Chemo-prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 years

• Number of Participants With Biochemical (PSA) Disease Progression

  12 months

• Number of Participants With Histological Disease Progression

  3 years

• Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D

  18 months + 30 days

Study Arms (6)

High dose Aspirin & Vitamin D

EXPERIMENTAL

Aspirin high dose (300mgs) daily \& Vitamin D 4,000 IU (0.1mg) per day

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)

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

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)

Drug: Low dose Aspirin, Vitamin D placebo

Aspirin Placebo, Vitamin D

EXPERIMENTAL

Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil

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

Drug: Aspirin placebo, Vitamin D placebo

Interventions

High dose Aspirin & Vitamin D DRUG

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

Also known as: Aspirin - acetylsalicylic acid, Vitamin D - Vigantol® Oil

High dose Aspirin & Vitamin D

High dose Aspirin, Vitamin D placebo DRUG

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

Also known as: Aspirin - acetylsalicylic acid, Vitamin D placebo - Miglyol®812 Oil

High dose Aspirin, Vitamin D placebo

Low dose Aspirin , Vitamin D DRUG

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

Also known as: Aspirin - acetylsalicylic acid, Vitamin D - Vigantol® Oil

Aspirin Placebo, Vitamin D; Low dose Aspirin , Vitamin D

Low dose Aspirin, Vitamin D placebo DRUG

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

Also known as: Aspirin - acetylsalicylic acid, Vitamin D placebo - Miglyol®812 Oil

Low dose Aspirin, Vitamin D placebo

Aspirin Placebo, Vitamin D DRUG

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

Also known as: Vitamin D - Vigantol® Oil

Aspirin Placebo, Vitamin D

Aspirin placebo, Vitamin D placebo DRUG

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

Also known as: Aspirin Placebo, Vitamin D, Vitamin D placebo - Miglyol®812 Oil

Aspirin placebo, Vitamin D placebo; High dose Aspirin, Vitamin D placebo

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts and the London School of Medicine and Dentistry: collaborator
• Cancer Research UK: collaborator

Study Sites (7)

Darent Valley Hospital

Dartford, DA2 8DA, United Kingdom

Location

University Hospital of Wales

London, CF14 4XW, United Kingdom

Location

University Hospital UHCW NHS Trust

London, CV2 2DX, United Kingdom

Location

St Bartholomews Hospital London, Bart's and the London school of Medicine

London, EC1A 7BE, United Kingdom

Location

University College Hospital London

London, NW1 2B, United Kingdom

Location

Homerton Hospital

London, United Kingdom

Location

Southampton General Hospital

Southampton, S016 6YD, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Aspirin; Vitamin D

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Professor Jack Cuzick, Director of The Wolfson Institute
• Organization: Queen Mary University, London.

j.cuzick@qmul.ac.uk

+44 (0)207 882 3504

Study Officials

• Greg Shaw, MD

  Queen Mary London

  PRINCIPAL INVESTIGATOR

• Jack Cuzick, PhD

  Queen Mary London

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: April 6, 2017
• Study Start: December 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)