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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Athene Lane, University of Bristol
ClinicalTrials.gov Identifier:
NCT01105338
First received: April 15, 2010
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
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
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Bristol:

Primary Outcome Measures:
  • Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trial recruitment and randomization rates at each stage of the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Intervention tolerability (adverse event reporting during the six months of follow-up) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Compliance (returned tablet counts and self-reported counts at 6 months) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Trial retention (participants completing 6-month follow-up and questionnaires) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PSA values at baseline and at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Weight and body mass index at 1 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure at 1 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Attitudes and views of men and their spouses about dietary modification and participation in long-term study (qualitative interviews conducted throughout the study) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Urinary symptoms as measured by the ICSmaleSF questionnaire (including voiding and incontinence scores, nocturia, frequency, and urinary-specific quality-of-life care data sources) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Green tea drink
Green tea drink
Behavioral: Green tea drink
Green tea drink
Active Comparator: Green tea capsules
Green tea capsules
Dietary Supplement: green tea capsules
green tea capsules
Placebo Comparator: Green tea placebo capsules
Green tea placebo capsules
Other: Green tea placebo capsules
Green tea placebo capsules
Active Comparator: Lycopene capsules
Lycopene capsules
Dietary Supplement: Lycopene capsules
Lycopene capsules
Placebo Comparator: Lycopene placebo capsules
Lycopene placebo capsules
Other: Lycopene placebo capsules
Lycopene placebo capsules
Active Comparator: Tomato rich diet
Tomato rich diet
Other: Tomato rich diet
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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105338

Locations
United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
Sponsors and Collaborators
University of Bristol
Investigators
Principal Investigator: Athene Lane, PhD University of Bristol
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Athene Lane, Study Coordinator and Senior Research Fellow, University of Bristol
ClinicalTrials.gov Identifier: NCT01105338     History of Changes
Other Study ID Numbers: C11046/A10052, ISRCTN-95931417
Study First Received: April 15, 2010
Last Updated: September 19, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Bristol:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014