No registrations found.
ID
Source
Brief title
Health condition
Minimal prostate cancer and rising PSA after radical prostatectomy.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Slope of the regression line through all two-weekly PSA measurements.
Secondary outcome
Plasma levels of testosterone, estradiol, DHEA, DHT, and SHBG, and IGF-1 during the intervention as compared to placebo.
Background summary
The goal of this protocol is to show an effect of a dietary supplement on PSA progression. This will be measured by the impact of the dietary supplement on the slope of a documented PSA rise, which is translatable into an effect on PSA doubling time. This approach is considered by the study group as the closest approximation of a tertiary prevention study, which is at this moment clinically feasible.
Extra safeguards will be filled in by run-in and washout periods, as well as by conducting animal experimental studies on human prostate cancer lines in nude mice.
The present protocol should produce evidence that may lead to the justification of more extensive studies that would more definitely establish the value of dietary intervention with supplements.
Study objective
A combination of Lycopene and Vitamin E decreases PSA progression.
Study design
N/A
Intervention
Lycopene 15 mg and Vitamin E 400 IU each day during 12 weeks versus placebo. After a washout period cross-over will take place.
P.O. Box 2040
F.H. Schröder
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634328
e.vandenberg@erasmusmc.nl
P.O. Box 2040
F.H. Schröder
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634328
e.vandenberg@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL95 |
| NTR-old | NTR126 |
| Other | : A300205 |
| ISRCTN | ISRCTN02859773 |
Summary results
Randomized, double-blind, placebo-controlled crossover study in men with prostate cancer and rising PSA: effectiveness of a dietary supplement.
Eur Urol. 2005 Dec;48(6):922-30; discussion 930-1. Epub 2005 Oct 17.