Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01105338
Protocol/serial number
Protocol version 1.1 (7th July 2008)
Study information
Scientific title
The feasibility of a randomised controlled trial of dietary interventions for men at high risk of prostate cancer: the ProDiet study
Acronym
ProDiet
Study hypothesis
This study aims to investigate the feasibility of recruiting men identified with an increased risk of prostate cancer into a randomised trial of dietary modification. Secondly, to investigate whether dietary modification results in elevated serum levels of the biological active dietary agents.
Ethics approval
Trent Multi-centre Research Ethics Committee (MREC), approved on 16/12/2008 (ref: 08/H0405/61)
Study design
Randomised 3 x 3 factorial design double-blind feasibility trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
Participants will each be randomly allocated to one of three lycopene-based/matched placebo interventions, and one of three green-tea-based/placebo interventions. Men will be asked to follow their allocated interventions for six months.
Lycopene-based interventions:
1. Dietary advice regarding a daily portion of cooked tomatoes (rich in Lycopene) plus matched placebo tablets
2. Tomato-derived lycopene supplement capsules (oral) daily (30 mg) with control dietary advice recommending five daily portions of fruit and vegetables
3. Control dietary advice recommending five daily portions of fruit and vegetables plus matched placebo tablets
Green-tea-based interventions:
A. Green tea capsules (oral) at 800 mg daily
B. Matched placebo supplement capsules
C. Advice to increase consumption of green tea
Intervention type
Drug
Phase
Not Applicable
Drug names
Lycopene, green tea
Primary outcome measures
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at six months following randomisation.
Secondary outcome measures
1. Trial recruitment and randomisation rates (measured at each stage of the study flowchart)
2. Intervention tolerability (adverse event reporting during the six months of follow-up)
3. Compliance (returned tablet counts and self reported counts at six months)
4. Trial retention (participants completing the six month follow-up and the questionnaires)
5. PSA values (measured at one and six months)
6. Dietary compliance with recommendations (dietary questionnaire completed at six months and participant data reporting dietary change)
7. Weight and body mass index (measured at one and six months) to assess whether the interventions have beneficial or deleterious effects on weight
8. Blood pressure (measured at one and six months) to assess whether there are any overall health benefits to the healthy diets
9. Attitudes and views of men and their spouses about dietary modification and participation in long term trials. Only a subset of participants will be included in this part of the study (one qualitative interview per participant; conducted throughout the study).
10. Anxiety, depression and pschycological state - measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States at enrolment, one month and six months
11. Urinary symptoms - measured at enrolment, one month and six months by the International Continence Society 'male short-form' (ICSmaleSF) questionnaire, which includes voiding and incontinence scores, nocturia, frequency and urinary-specific quality of life care data sources
Overall trial start date
01/04/2009
Overall trial end date
30/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 50-69 years on the date of preparation of the list at the general practice of potential participants for the ProtecT study (registered with ISRCTN20141297)
2. Male gender
3. ProtecT participants with a prostate-specific antigen (PSA) test between 2.5 to 2.95 ng/ml or a PSA level of at least 3.0 ng/ml with a negative biopsy (10 core procedure) from the ProtecT study
4. Enrolled in the ProMPT study and willing to be contacted about further studies
5. Able to give informed written consent to participate
6. Registration with the participating general practice
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
126
Participant exclusion criteria
1. A PSA >=20 ng/ml (indication of prostate cancer or prostatitis)
2. History of allergic reactions to green tea or lycopene containing products (including guava, watermelon)
3. Concurrent medication with finasteride or dutasteride (elevates PSA values)
Recruitment start date
01/04/2009
Recruitment end date
30/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Social Medicine
Bristol
BS8 2PS
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
c/o Anna Brooke
Research Governance Officer
University of Bristol
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (ref: C11046/A10052)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary