|- candidate number||1209|
|- NTR Number||NTR126|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||22-aug-2005|
|- Secondary IDs||A300205 |
|- Public Title||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.|
|- Scientific Title||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.|
|- ACRONYM||BASF dietary study|
|- hypothesis||A combination of Lycopene and Vitamin E decreases PSA progression.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- 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;|
3. Chemotherapy, radiotherapy or TURP prior to study resulting in PSA decrease that is currently ongoing.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-jan-2003|
|- planned closingdate||30-jun-2006|
|- Target number of participants||80|
|- 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.|
|- 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.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. F.H. Schröder|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.F. Wildhagen|
|- Sponsor/Initiator ||BASF Aktiengesellschaft|
(Source(s) of Monetary or Material Support)
|- Publications||Schroder FH, Roobol MJ, Boeve ER, de Mutsert R, Zuijdgeest-van Leeuwen SD, Kersten I, Wildhagen MF, van Helvoort A.|
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.
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||16-aug-2005 - 26-nov-2008|