Prostagen Study - Investigation of polymorphisms in genes of the fatty acid metabolism in relation to the evolvement and further development of prostate cancer

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00000319
• Lead Sponsor: Klinik für Tumorbiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Study Completion: 2012-01-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 158

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:
* 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.