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Completed

NCT Number: NCT01105338

Lycopene or Green Tea for 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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Southmead Hospital

Bristol, England, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green tea drink

Behavioral

Green tea drink

green tea capsules

Dietary Supplement

green tea capsules

Green tea placebo capsules

Other

Green tea placebo capsules

Lycopene capsules

Dietary Supplement

Lycopene capsules

Lycopene placebo capsules

Other

Lycopene placebo capsules

Tomato rich diet

Other

Tomato rich diet

Primary outcomes

  1. Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization

    Time frame: 6 months

Secondary outcomes

  1. Trial recruitment and randomization rates at each stage of the study

    Time frame: 6 months

  2. Intervention tolerability (adverse event reporting during the six months of follow-up)

    Time frame: 6 months

  3. Compliance (returned tablet counts and self-reported counts at 6 months)

    Time frame: 6 months

  4. Trial retention (participants completing 6-month follow-up and questionnaires)

    Time frame: 6 months

  5. PSA values at baseline and at 6 months

    Time frame: 6 months

  6. Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change)

    Time frame: 6 months

  7. Weight and body mass index at 1 and 6 months

    Time frame: 6 months

  8. Blood pressure at 1 and 6 months

    Time frame: 6 months

  9. 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

  10. Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States

    Time frame: 6 months

  11. 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

Sponsors and collaborators

Lead sponsor

University of Bristol

Other

Registry information

Official study title

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

Acronym: ProDiet

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2010
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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