Lycopene and vitamin E in men with minimal prostate cancer and rising prostate specific antigen after radical prostatectomy: a double blind randomised placebo controlled cross-over study
| ISRCTN | ISRCTN02859773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02859773 |
| Secondary identifying numbers | A300205; NTR126 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 13/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof F.H. Schröder
Scientific
Scientific
Department of Urology
Erasmus Medical Centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 463 4328 |
|---|---|
| e.vandenberg@erasmusmc.nl |
Study information
| Study design | Randomised, placebo controlled, crossover group, double blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | BASF dietary study |
| Study objectives | The goal of this protocol is to show an effect of a dietary supplement on prostate specific antigen (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. Hypothesis: A combination of Lycopene and Vitamin E decreases PSA progression. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Lycopene 15 mg and Vitamin E 400 IU each day during 12 weeks versus placebo. After a washout period, a cross-over will take place. |
| Intervention type | Supplement |
| Primary outcome measure | Slope of the regression line through all two-weekly PSA measurements. |
| Secondary outcome measures | Plasma levels of testosterone, oestradiol, dehydroepiandrosterone (DHEA), dihydrotestosterone (DHT), and sex hormone-binding globulin (SHBG), and insulin-like growth factor 1 (IGF-1) during the intervention as compared to placebo. |
| Overall study start date | 27/01/2003 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Status after radical prostatectomy with potential curative intent 2. Rising PSA 3. Life expectancy more than or equal to 12 months 4. Age more than or equal to 18 years |
| Key exclusion criteria | 1. Current hormone therapy or hormone therapy during previous 12 months 2. Orchidectomy 3. Chemotherapy, radiotherapy or transurethral resection of the prostate (TURP) prior to study resulting in PSA decrease that is currently ongoing |
| Date of first enrolment | 27/01/2003 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Urology
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
BASF Aktiengesellschaft (Germany)
Industry
Industry
Carl-Bosch-Str. 38
Ludwigshafen
DE-67063
Germany
| Website | http://corporate.basf.com/de/?id=V00-MtkCyA4GZbcp.sn |
|---|---|
"ROR" |
https://ror.org/01q8f6705 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/12/2005 | Yes | No |
