Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof F.H. Schröder

ORCID ID

Contact details

Department of Urology
Erasmus Medical Centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 4328
e.vandenberg@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A300205; NTR126

Study information

Scientific title

Acronym

BASF dietary study

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised, placebo controlled, crossover group, double blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Lycopene, Vitamin E

Primary outcome measures

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 trial start date

27/01/2003

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

80

Participant 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

Recruitment start date

27/01/2003

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Urology
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

BASF Aktiengesellschaft (Germany)

Sponsor details

Carl-Bosch-Str. 38
Ludwigshafen
DE-67063
Germany

Sponsor type

Industry

Website

http://corporate.basf.com/de/?id=V00-MtkCyA4GZbcp.sn

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16263208

Publication citations

  1. Results

    Schröder FH, Roobol MJ, Boevé 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, 48, 6, 922-30; discussion 930-1, doi: 10.1016/j.eururo.2005.08.005.

Additional files

Editorial Notes