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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN-95931417 | Registry Identifier | ISRCTN |
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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
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green tea drink | Active Comparator | Green tea drink |
|
| Green tea capsules | Active Comparator | Green tea capsules |
|
| Green tea placebo capsules | Placebo Comparator | Green tea placebo capsules |
|
| Lycopene capsules | Active Comparator | Lycopene capsules |
|
| Lycopene placebo capsules | Placebo Comparator | Lycopene placebo capsules |
|
| Tomato rich diet | Active Comparator | Tomato rich diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea drink | Behavioral | Green tea drink |
| |
| green tea capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization | 6 months |
| 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 | |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Athene Lane, PhD | University of Bristol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southmead Hospital | Bristol | England | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013662 | Tea |
| D000077276 | Lycopene |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Dietary Supplement |
green tea capsules |
|
| Green tea placebo capsules | Other | Green tea placebo capsules |
|
| Lycopene capsules | Dietary Supplement | Lycopene capsules |
|
| Lycopene placebo capsules | Other | Lycopene placebo capsules |
|
| Tomato rich diet | Other | Tomato rich diet |
|
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |