Lycopene and Vitamin E in men with minimal prostate cancer and rising PSA after radical prostatectomy. A double blind randomised placebo controlled cross-over study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25453

Enrollment

Registered

2005-08-22

Start date

2003-01-27

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal prostate cancer and rising PSA after radical prostatectomy.

Interventions

Lycopene 15 mg and Vitamin E 400 IU each day during 12 weeks versus placebo. After a washout period cross-over will take place.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Status after radical prostatectomy with potential curative intent; 2. Rising PSA; 3. Life expectancy >= 12 months; 4. Age >= 18 years.

Exclusion criteria

Exclusion criteria: 1. Current hormone therapy or hormone therapy during previous 12 months; 2. Orchidectomy; 3. Chemotherapy, radiotherapy or TURP prior to study resulting in PSA decrease that is currently ongoing.

Design outcomes

Primary

Measure	Time frame
Slope of the regression line through all two-weekly PSA measurements.	—

Secondary

Measure	Time frame
Plasma levels of testosterone, estradiol, DHEA, DHT, and SHBG, and IGF-1 during the intervention as compared to placebo.	—

Contacts

Public ContactF.H. Schröder

Erasmus Medical Center, Department of Urology, P.O. Box 2040

e.vandenberg@erasmusmc.nl+31 (0)10 4634328

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)