Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
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 all
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum lycopene and epigallocatechin-3-gallate (green tea) levels at six months following randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed