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
2 other identifiers
interventional
126
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Aug 2009
Shorter than P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJanuary 23, 2018
January 1, 2018
1 year
April 15, 2010
January 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
6 months
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (6)
Green tea drink
ACTIVE COMPARATORGreen tea drink
Green tea capsules
ACTIVE COMPARATORGreen tea capsules
Green tea placebo capsules
PLACEBO COMPARATORGreen tea placebo capsules
Lycopene capsules
ACTIVE COMPARATORLycopene capsules
Lycopene placebo capsules
PLACEBO COMPARATORLycopene placebo capsules
Tomato rich diet
ACTIVE COMPARATORTomato rich diet
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southmead Hospital
Bristol, England, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athene Lane, PhD
University of Bristol
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Coordinator and Senior Research Fellow
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 16, 2010
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
January 23, 2018
Record last verified: 2018-01