Lycopene or Green Tea for Men at Risk of Prostate Cancer (ProDiet)

University of Bristol

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Dietary Supplement: green tea capsules; Other: Tomato rich diet; Other: Lycopene placebo capsules; Behavioral: Green tea drink; Dietary Supplement: Lycopene capsules; Other: Green tea placebo capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT01105338

C11046/A10052

ISRCTN-95931417 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 126 patients

Sex: Male

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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126 participants in 6 patient groups, including a placebo group

Green tea drink

Active Comparator group

Description:

Green tea drink

Treatment:

Behavioral: Green tea drink

Green tea capsules

Active Comparator group

Description:

Green tea capsules

Treatment:

Dietary Supplement: green tea capsules

Green tea placebo capsules

Placebo Comparator group

Description:

Green tea placebo capsules

Treatment:

Other: Green tea placebo capsules

Lycopene capsules

Active Comparator group

Description:

Lycopene capsules

Treatment:

Dietary Supplement: Lycopene capsules

Lycopene placebo capsules

Placebo Comparator group

Description:

Lycopene placebo capsules

Treatment:

Other: Lycopene placebo capsules

Tomato rich diet

Active Comparator group

Description:

Tomato rich diet

Treatment:

Other: Tomato rich diet