Prostate and Diet Study (ProDiet Study): dietary interventions for men at high risk of prostate cancer - feasibility study

ISRCTN	ISRCTN95931417
DOI	https://doi.org/10.1186/ISRCTN95931417
ClinicalTrials.gov (NCT)	NCT01105338
Protocol serial number	Protocol version 1.1 (07/07/2008)
Sponsor	University of Bristol (UK)
Funder	Cancer Research UK (ref: C11046/A10052)

Submission date: 27/02/2009
Registration date: 13/03/2009
Last edited: 11/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/trials-search/a-study-men-at-risk-prostate-cancer-can-increase-levels-lycopene-and-green-tea-prodiet

Contact information

Dr Athene Lane
Scientific

Department of Social Medicine
Bristol University
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised 3 x 3 factorial design double-blind feasibility trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The feasibility of a randomised controlled trial of dietary interventions for men at high risk of prostate cancer: the ProDiet study
Study acronym	ProDiet
Study objectives	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(s)	Trent Multi-centre Research Ethics Committee (MREC), approved on 16/12/2008 (ref: 08/H0405/61)
Health condition(s) or problem(s) studied	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	Supplement
Primary outcome measure(s)	Serum lycopene and epigallocatechin-3-gallate (green tea) levels at six months following randomisation
Key secondary outcome measure(s)	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
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	126
Total final enrolment	128
Key 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
Key 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)
Date of first enrolment	01/04/2009
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Bristol University

Bristol
BS8 2PS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	nested interview study results	03/05/2014		Yes	No
Results article	nested interview study results	05/11/2014		Yes	No
Results article	results	15/04/2019	11/07/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/07/2019: Publication reference and total final enrolment added.
23/03/2018: Publication references added.