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

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Bristol, England, United Kingdom
      • Southmead Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Green tea drink	Behavioral: Green tea drink; Green tea drink
Active Comparator: Green tea capsules	Dietary supplement: green tea capsules; green tea capsules
Placebo Comparator: Green tea placebo capsules	Other: Green tea placebo capsules; Green tea placebo capsules
Active Comparator: Lycopene capsules	Dietary supplement: Lycopene capsules; Lycopene capsules
Placebo Comparator: Lycopene placebo capsules	Other: Lycopene placebo capsules; Lycopene placebo capsules
Active Comparator: Tomato rich diet	Other: Tomato rich diet; Tomato rich diet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Bristol
• Investigators: Principal Investigator: Athene Lane, PhD, University of Bristol

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Lycopene
• Other Study ID Numbers: C11046/A10052; ISRCTN-95931417 (Registry Identifier: ISRCTN)