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 number | NCT01105338 |
| Secondary identifying numbers | Protocol version 1.1 (07/07/2008) |
- 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
Contact information
Dr Athene Lane
Scientific
Scientific
Department of Social Medicine
Bristol University
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Study information
| Study design | Randomised 3 x 3 factorial design double-blind feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/04/2009 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Bristol University
Bristol
BS8 2PS
United Kingdom
BS8 2PS
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
c/o Anna Brooke
Research Governance Officer
University of Bristol
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Website | http://www.bris.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
Cancer Research UK (ref: C11046/A10052)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
23/03/2018: Publication references added.
