Lycopene or Green Tea for Men at Risk of Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or green tea may be more effective in preventing prostate cancer. PURPOSE: This randomized phase II trial is studying lycopene to see how well it works compared with green tea in preventing prostate cancer in patients previously enrolled in the ProtecT trial

Detailed Description
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OBJECTIVES: Primary To assess serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization in patients with prostate cancer previously enrolled on ProtecT Secondary To evaluate trial recruitment and randomization rates of patients treated with this regimen. To evaluate intervention tolerability in patients treated with this regimen. To evaluate compliance of patients treated with this regimen. To evaluate trial retention of patients treated with this regimen. To assess PSA values in patients treated with this regimen. To evaluate dietary compliance with recommendations of patients treated with this regimen. To assess weight and body mass index of patients treated with this regimen. To evaluate attitudes and views of men and their spouses about dietary modification and participation in long-term study. OUTLINE: Patients are stratified according to PSA test levels obtained from ProtecT study recruitment clinic (< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2 treatment arms.

Official Title
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Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Green tea drink
* Dietary Supplement: green tea capsules
* Other: Green tea placebo capsules
* Dietary Supplement: Lycopene capsules
* Other: Lycopene placebo capsules
* Other: Tomato rich diet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.0 ng/mL with a negative biopsy No major comorbidities No other cancers or prior prostate malignancy No history of allergic reactions to green tea or lycopene-containing products, including guava or watermelon Exclusion criteria: No concurrent finasteride or dutasteride

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Green tea drink<br>Green tea drink | Behavioral: Green tea drink<br>* Green tea drink<br>|
| Active Comparator: Green tea capsules<br>Green tea capsules | Dietary Supplement: green tea capsules<br>* green tea capsules<br>|
| Placebo Comparator: Green tea placebo capsules<br>Green tea placebo capsules | Other: Green tea placebo capsules<br>* Green tea placebo capsules<br>|
| Active Comparator: Lycopene capsules<br>Lycopene capsules | Dietary Supplement: Lycopene capsules<br>* Lycopene capsules<br>|
| Placebo Comparator: Lycopene placebo capsules<br>Lycopene placebo capsules | Other: Lycopene placebo capsules<br>* Lycopene placebo capsules<br>|
| Active Comparator: Tomato rich diet<br>Tomato rich diet | Other: Tomato rich diet<br>* Tomato rich diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial recruitment and randomization rates at each stage of the study |  | 6 months | 
| Intervention tolerability (adverse event reporting during the six months of follow-up) |  | 6 months | 
| Compliance (returned tablet counts and self-reported counts at 6 months) |  | 6 months | 
| Trial retention (participants completing 6-month follow-up and questionnaires) |  | 6 months | 
| PSA values at baseline and at 6 months |  | 6 months | 
| Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change) |  | 6 months | 
| Weight and body mass index at 1 and 6 months |  | 6 months | 
| Blood pressure at 1 and 6 months |  | 6 months | 
| Attitudes and views of men and their spouses about dietary modification and participation in long-term study (qualitative interviews conducted throughout the study) |  | 6 months | 
| Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States |  | 6 months | 
| Urinary symptoms as measured by the ICSmaleSF questionnaire (including voiding and incontinence scores, nocturia, frequency, and urinary-specific quality-of-life care data sources) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer