Trial Description

DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Prostagen Study - Investigation of polymorphisms in genes of the fatty acid
metabolism in relation to the evolvement and further development of prostate
cancer
Trial Acronym
[---]*
URL of the trial
[---]*
Brief Summary in Lay Language
The aim of this study is to develop a genetic test able to predict the individual
course of disease (aggressiveness) in patients with prostate cancer. An accurate
prediction could allow a better decision on the most suitable treatment for the
individual patient.
It will also seek to clarify if a supplementation with omega-3 fatty acids in form of
marine phospholipids (Vitalipin ® capsules) could achieve a reduction of prostate
specific antigen (PSA) in the blood.
Brief Summary in Scientific Language
The primary study objective is to determine polymorphisms (SNPs) in genes of the
fatty acid metabolism and its possible correlation with the incidence of prostate
cancer, as well as with the severity of the disease.
A secondary objective is to examine changes in the fatty acid composition in blood
samples after an intake of omega-3 fatty acids in form of phospholipids over a
period of three months (as dietary supplementation) and whether these changes
depend on the individual SNPs constellation.
Based on the results of this research, an improved decision regarding therapy
and/or dietary recommendations (in relation to omega-3-fatty acids) the most
suitable for each patient, could be created.
Organizational Data
DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
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DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 341/09 , Ethik-Kommission der Albert-LudwigsUniversität Freiburg
Secondary IDs
Universal Trial Number (UTN): U1111-1113-4482
Health condition or Problem studied
ICD10: C61 - Malignant neoplasm of prostate
ICD10: [---]* - [---]*
Interventions/Observational Groups
Arm 1: Patients supplemented with omega-3 fatty acids (Vitalipin, marine
phospholipids). Dose: 3 x 500mg per day during 3 months.
Arm 2: Healthy subject supplemented with omega-3 fatty acids (Vitalipin,
marine phospholipids). Dose: 3 x 500mg per day during 3 months.
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Non-randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Basic research/physiological study
Assignment: Parallel
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]*
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DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
Primary Outcome
Analysis of polymorphisms (SNPs) in genes of the fatty acid metabolism will be
done to each patient / healthy subject at the beginning of the study.
Secondary Outcome
To assess changes in the fatty acid composition in plasma after the
supplementation with the omega-3-preparation and its relation to the found SNP.
Phospholipids, lysolipids and their fatty acid composition in plasma at baseline
and after three months of omega-3-intake will be analyzed.
Countries of recruitment
DE Germany
Locations of Recruitment
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2009/12/07
Target Sample Size: 150
Monocenter/Multicenter trial: Multicenter trial
National/International: National
Inclusion Criteria
Gender: Male
Minimum Age: 18 Years
Maximum Age: no maximum age
Additional Inclusion Criteria
Patient inclusion criteria:
- Patients with histologically proven prostate cancer who are treated or advised in
one of the centers involved in the study
- Written informed consent
Inclusion criteria for healthy subjects:
- Subjects without prostate cancer or any other tumor, which are screened in one
of the study centers and are 70 years or older.
- Exclusion of prostate cancer according to one of the following criteria:
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DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
* Men with a PSA level of maximum 10 ng/ml, who underwent a 12x punch biopsy
with a negative result.
* Men with benign prostatic hyperplasia (BPH), in whom a transurethral resection
of the prostate (TUR-P) was conducted and the histology of the recovered material
was negative (PSA maximum 10 ng /l).
* PSA less than 4ng/l and no prostate cancer family history
- Written informed consent
Exclusion criteria
- Patients / healthy subjects with a known allergy to seafood
- Patients / healthy subjects who can not eat or are on a special diet
- Patients / healthy subjects with malabsorption (i.e. after gastrointestinal
surgery, inflammatory bowel disease)
- Patients / healthy subjects with severe internal diseases, especially with
impaired coagulation, liver or gall bladder disease, bile duct tumors, or
pancreatitis
- Patients / healthy subjects who are already taking omega-3 fatty acids
supplementation or other dietary supplements and drugs that are likely to affect
the results of the research
- Patients / healths subjects with psychiatric or CNS disorders, who are not able to
consent to participation in the study
Addresses
Primary Sponsor
Klinik für Tumorbiologie
Mr. Prof. Dr. Ulrich Massing
Breisacher Str. 117
79106 Freiburg i. Br.
Germany
Telephone: +49 (0) 761 206 2177
Fax: +49 (0) 761 206 261 2177
E-mail: massing at tumorbio.uni-freiburg.de
URL: http://www.tumorbio.uni-freiburg.de/
Contact for Scientific Queries
Klinik für Tumorbiologie
Mr. Prof. Dr. Ulrich Massing
Breisacher Str. 117
79106 Freiburg i. Br.
Germany
Telephone: +49 (0) 761 206 2177
Fax: +49 (0)761 206 261 2177
E-mail: massing at tumorbio.uni-freiburg.de
URL: http://www.tumorbio.uni-freiburg.de/
Contact for Public Queries
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DRKS-ID: DRKS00000319
Date of Registration in DRKS: 2010/02/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
Contact for Public Queries
Klinik für Tumorbiologie
Ms. Daniela Küllenberg
Breisacher Str. 117
79106 Freiburg i. Br.
Germany
Telephone: +49 (0) 761 206 2933
Fax: [---]*
E-mail: kuellenberg at tumorbio.uni-freiburg.de
URL: http://www.tumorbio.uni-freiburg.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body
(German Research Foundation (DFG), Federal Ministry of Education and
Research (BMBF), etc.)
Bundesministerium für Bildung und Forschung (BMBF)
53170 Bonn
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: http://www.bmbf.de/
Status
Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2012/01/03
Trial Publications, Results and other documents
* This entry means the parameter is not applicable or has not been set.
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