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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.


- candidate number1209
- NTR NumberNTR126
- ISRCTNISRCTN02859773
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR22-aug-2005
- Secondary IDsA300205 
- Public TitleLycopene 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 TitleLycopene and Vitamin E in men with minimal prostate cancer and rising PSA after radical prostatectomy. A double blind randomised placebo controlled cross-over study.
- ACRONYMBASF dietary study
- hypothesisA combination of Lycopene and Vitamin E decreases PSA progression.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. Status after radical prostatectomy with potential curative intent;
2. Rising PSA;
3. Life expectancy >= 12 months;
4. Age >= 18 years.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-jan-2003
- planned closingdate30-jun-2006
- Target number of participants80
- InterventionsLycopene 15 mg and Vitamin E 400 IU each day during 12 weeks versus placebo. After a washout period cross-over will take place.
- Primary outcomeSlope of the regression line through all two-weekly PSA measurements.
- Secondary outcomePlasma levels of testosterone, estradiol, DHEA, DHT, and SHBG, and IGF-1 during the intervention as compared to placebo.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. F.H. Schröder
- CONTACT for SCIENTIFIC QUERIESDr. M.F. Wildhagen
- Sponsor/Initiator BASF Aktiengesellschaft
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsSchroder 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 summaryThe 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)
- RECORD16-aug-2005 - 26-nov-2008


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