ycopene and vitamin E in men with minimal prostate cancer and rising prostate specific antigen after radical prostatectomy: a double blind randomised placebo controlled cross-over study

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN02859773
• Lead Sponsor: BASF Aktiengesellschaft (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. Status after radical prostatectomy with potential curative intent
2. Rising PSA
3. Life expectancy more than or equal to 12 months
4. Age more than or equal to 18 years

Exclusion Criteria

1. Current hormone therapy or hormone therapy during previous 12 months
2. Orchidectomy
3. Chemotherapy, radiotherapy or transurethral resection of the prostate (TURP) prior to study resulting in PSA decrease that is currently ongoing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Slope of the regression line through all two-weekly PSA measurements.

Secondary Outcome Measures

Name	Time	Method
Plasma levels of testosterone, oestradiol, dehydroepiandrosterone (DHEA), dihydrotestosterone (DHT), and sex hormone-binding globulin (SHBG), and insulin-like growth factor 1 (IGF-1) during the intervention as compared to placebo.