Prostate CancerPhase 2/3ProDietNCT01105338
Lycopene or Green Tea for Men at Risk of Prostate Cancer
A Phase 2/3 study testing Green tea drink, green tea capsules and Lycopene capsules in people with Prostate Cancer, run by University of Bristol at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Green tea drink, green tea capsules and Lycopene capsules
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Aug 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Green tea drink, green tea capsules, Green tea placebo capsules, Lycopene capsules, Lycopene placebo capsules
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea drinkBehavioural
Green tea drink
green tea capsulesDietary supplement
green tea capsules
Green tea placebo capsulesOther
Green tea placebo capsules
Lycopene capsulesDietary supplement
Lycopene capsules
Lycopene placebo capsulesOther
Lycopene placebo capsules
Tomato rich dietOther
Tomato rich diet
| Study group | Role | What they receive |
|---|---|---|
| Green tea drink | Active comparator | Green tea drink Receives: Behavioral: Green tea drink |
| Green tea capsules | Active comparator | Green tea capsules Receives: Dietary Supplement: green tea capsules |
| Green tea placebo capsules | Placebo comparator | Green tea placebo capsules Receives: Other: Green tea placebo capsules |
| Lycopene capsules | Active comparator | Lycopene capsules Receives: Dietary Supplement: Lycopene capsules |
| Lycopene placebo capsules | Placebo comparator | Lycopene placebo capsules Receives: Other: Lycopene placebo capsules |
| Tomato rich diet | Active comparator | Tomato rich diet Receives: Other: Tomato rich diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
Measured: 6 months
Secondary outcomes (11)
Trial recruitment and randomization rates at each stage of the study
Measured: 6 months
Intervention tolerability (adverse event reporting during the six months of follow-up)
Measured: 6 months
Compliance (returned tablet counts and self-reported counts at 6 months)
Measured: 6 months
Trial retention (participants completing 6-month follow-up and questionnaires)
Measured: 6 months
PSA values at baseline and at 6 months
Measured: 6 months
Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change)
Measured: 6 months
Weight and body mass index at 1 and 6 months
Measured: 6 months
Blood pressure at 1 and 6 months
Measured: 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)
Measured: 6 months
Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Athene Lane, University of Bristol
- Investigators
- Athene Lane, PhD, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105338
- Sponsor's protocol ID
- C11046/A10052
- Other IDs
- ISRCTN-95931417
- Acronym
- ProDiet
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2010
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01105338
- Acronym / sponsor ID
- ProDiet / C11046/A10052
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Green tea drink | Active comparator | Behavioral: Green tea drinkGreen tea drink |
| Green tea capsules | Active comparator | Dietary Supplement: green tea capsulesGreen tea capsules |
| Green tea placebo capsules | Placebo comparator | Other: Green tea placebo capsulesGreen tea placebo capsules |
| Lycopene capsules | Active comparator | Dietary Supplement: Lycopene capsulesLycopene capsules |
| Lycopene placebo capsules | Placebo comparator | Other: Lycopene placebo capsulesLycopene placebo capsules |
| Tomato rich diet | Active comparator | Other: Tomato rich dietTomato rich diet |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea drinkGreen tea drink | Behavioural | Green tea drink |
| green tea capsulesgreen tea capsules | Dietary supplement | Green tea capsules |
| Green tea placebo capsulesGreen tea placebo capsules | Other | Green tea placebo capsules |
| Lycopene capsulesLycopene capsules | Dietary supplement | Lycopene capsules |
| Lycopene placebo capsulesLycopene placebo capsules | Other | Lycopene placebo capsules |
| Tomato rich dietTomato rich diet | Other | Tomato rich diet |
Primary outcome
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
Time frame: 6 months
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athene Lane, PhD principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Green tea drink, green tea capsules and Lycopene capsules in people with Prostate Cancer, run by University of Bristol at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.