Clinical trial NCT01105338: Lycopene or Green Tea for Men at Risk of Prostate Cancer
Official title: Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: University of Bristol
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 126
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
timeFrame: 6 months
Secondary outcomes:
measure: Trial recruitment and randomization rates at each stage of the study
timeFrame: 6 months
measure: Intervention tolerability (adverse event reporting during the six months of follow-up)
timeFrame: 6 months
measure: Compliance (returned tablet counts and self-reported counts at 6 months)
timeFrame: 6 months
measure: Trial retention (participants completing 6-month follow-up and questionnaires)
timeFrame: 6 months
measure: PSA values at baseline and at 6 months
timeFrame: 6 months
measure: Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change)
timeFrame: 6 months
measure: Weight and body mass index at 1 and 6 months
timeFrame: 6 months
measure: Blood pressure at 1 and 6 months
timeFrame: 6 months
measure: Attitudes and views of men and their spouses about dietary modification and participation in long-term study (qualitative interviews conducted throughout the study)
timeFrame: 6 months
measure: Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States
timeFrame: 6 months
measure: Urinary symptoms as measured by the ICSmaleSF questionnaire (including voiding and incontinence scores, nocturia, frequency, and urinary-specific quality-of-life care data sources)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
Study officials:
affiliation: University of Bristol
name: Athene Lane, PhD
role: PRINCIPAL_INVESTIGATOR
References: