A combination of Lycopene and Vitamin E decreases PSA progression.
ID
Bron
Verkorte titel
Aandoening
Minimal prostate cancer and rising PSA after radical prostatectomy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Slope of the regression line through all two-weekly PSA measurements.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
A combination of Lycopene and Vitamin E decreases PSA progression.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Lycopene 15 mg and Vitamin E 400 IU each day during 12 weeks versus placebo. After a washout period cross-over will take place.
Publiek
P.O. Box 2040
F.H. Schröder
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634328
e.vandenberg@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040
F.H. Schröder
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634328
e.vandenberg@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Status after radical prostatectomy with potential curative intent;
2. Rising PSA;
3. Life expectancy >= 12 months;
4. Age >= 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL95 |
| NTR-old | NTR126 |
| Ander register | : A300205 |
| ISRCTN | ISRCTN02859773 |
Samenvatting resultaten
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.