Lycopene or Green Tea for Men at Risk of Prostate Cancer

Prostate Cancer Clinical Trial

— ProDiet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105338
• Other study ID #: C11046/A10052
• Secondary ID: ISRCTN-95931417
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 15, 2010
• Last updated: January 19, 2018
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2018
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Green tea drink
Green tea drink

Dietary Supplement:
• green tea capsules
green tea capsules

Other:
• Green tea placebo capsules
Green tea placebo capsules

Dietary Supplement:
• Lycopene capsules
Lycopene capsules

Other:
• Lycopene placebo capsules
Lycopene placebo capsules
• Tomato rich diet
Tomato rich diet

Locations

Country	Name	City	State
United Kingdom	Southmead Hospital	Bristol	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization		6 months
Secondary	Trial recruitment and randomization rates at each stage of the study		6 months
Secondary	Intervention tolerability (adverse event reporting during the six months of follow-up)		6 months
Secondary	Compliance (returned tablet counts and self-reported counts at 6 months)		6 months
Secondary	Trial retention (participants completing 6-month follow-up and questionnaires)		6 months
Secondary	PSA values at baseline and at 6 months		6 months
Secondary	Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change)		6 months
Secondary	Weight and body mass index at 1 and 6 months		6 months
Secondary	Blood pressure at 1 and 6 months		6 months
Secondary	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
Secondary	Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States		6 months
Secondary	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

External Links

•   ProtecT trial with link to ProDiet page