Lycopene or Green Tea in Treating Patients With Prostate Cancer Previously Enrolled on RADCLIFFE-PROTECT and Currently Enrolled on CRUK-ProMPT

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

• Trial recruitment and randomization rates at each stage of the study [ Designated as safety issue: No ]
  
• Intervention tolerability (adverse event reporting during the six months of follow-up) [ Designated as safety issue: Yes ]
  
• Compliance (returned tablet counts and self-reported counts at 6 months) [ Designated as safety issue: No ]
  
• Trial retention (participants completing 6-month follow-up and questionnaires) [ Designated as safety issue: No ]
  
• PSA values at baseline and at 6 months [ Designated as safety issue: No ]
  
• Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change) [ Designated as safety issue: No ]
  
• Weight and body mass index at 1 and 6 months [ Designated as safety issue: No ]
  
• Blood pressure at 1 and 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) [ 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 [ 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) [ Designated as safety issue: No ]
  

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 RADCLIFFE-PROTECT and currently enrolled on CRUK-ProMPT treated with lycopene versus green tea.

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: This is a multicenter study. Patients are stratified according to PSA test levels obtained from RADCLIFFE-PROTECT study recruitment clinic (< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2 treatment arms.

• Arm I (lycopene): Patients receive 1 of the following treatment regimes.

  • Regimen 1: Patients receive dietary advice regarding a daily portion of cooked tomatoes rich in lycopene. Patients also receive oral placebo capsules once daily.
  • Regimen 2: Patients also receive dietary advice recommending 5 daily portions of fruit and vegetables. Patients also receive tomato-derived lycopene supplement capsules once daily. .
  • Regimen 3: Patients receive healthy dietary advice. Patients also receive oral placebo capsules once daily.

• Arm II (green tea): Patients receive 1 of the following treatment regimes.

  • Regimen 1: Patients receive oral green tea capsules once daily.
  • Regimen 2: Patients receive oral placebo capsules once daily.
  • Regimen 3: Patients receive dietary advice regarding drinking green tea. Patients complete quality-of-life questionnaires on urinary symptoms (ICSmaleSF questionnaire/FTQ1), general health status [Hospital Anxiety and Depression scale (HAD) and Profile of Moods States], and current diet (Food Frequency Questionnaire/FTQ1a) periodically.

Patients are followed at 1 and 6 months after randomization.

Peer Reviewed and Funded or Endorsed by Cancer Research UK