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

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ClinicalTrials.gov Identifier: NCT01105338

Recruitment Status : Completed

First Posted : April 16, 2010

Last Update Posted : January 23, 2018

Sponsor:

Information provided by (Responsible Party):

Dr Athene Lane, University of Bristol

Study Description

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

Condition or disease	Intervention/treatment	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

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	126 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer
Study Start Date :	August 2009
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	August 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Lycopene Camellia sinensis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization [ Time Frame: 6 months ]

Secondary Outcome Measures :

Trial recruitment and randomization rates at each stage of the study [ Time Frame: 6 months ]
Intervention tolerability (adverse event reporting during the six months of follow-up) [ Time Frame: 6 months ]
Compliance (returned tablet counts and self-reported counts at 6 months) [ Time Frame: 6 months ]
Trial retention (participants completing 6-month follow-up and questionnaires) [ Time Frame: 6 months ]
PSA values at baseline and at 6 months [ Time Frame: 6 months ]
Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change) [ Time Frame: 6 months ]
Weight and body mass index at 1 and 6 months [ Time Frame: 6 months ]
Blood pressure at 1 and 6 months [ Time Frame: 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) [ Time Frame: 6 months ]
Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States [ Time Frame: 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) [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years to 69 Years (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


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 ( Registry Identifier: ISRCTN )
First Posted:	April 16, 2010 Key Record Dates
Last Update Posted:	January 23, 2018
Last Verified:	January 2018

Keywords provided by Dr Athene Lane, 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	Carotenoids Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents

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