Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia

NCT ID: NCT06380062

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-12

Study Completion Date

2015-11-30

Brief Summary

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The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age.

Detailed Description

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This observational study recruited participants with primary prostate cancer (cases) and those with benign hyperplasia (controls) before the surgery. Data on the outcomes of the surgery including the results of the biopsy investigation were collected. Blood samples were collected before the surgery in context of routine blood investigations. Blood plasma samples collected on ethylenediaminetetraacetic acid (EDTA) were used to measure concentrations of free choline, betaine, dimethylglycine, folate forms, S-adenosylhomocysteine, S-adenosylmethionine, homocysteine, cystathionine, and methylmalonic acid (MMA). Data on serum concentrations of prostate specific antigen (PSA) and the tumor grade and classification (Gleason Score system) were collected. The associations between the plasma concentrations of the metabolites and PSA or the Gleason score were studied. The concentrations of the metabolic markers were compared between the cases and the controls according to the age of the participants.

Conditions

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Primary Prostate Urothelial Cancer Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Primary prostate cancer

Men participants diagnosed with primary prostate cancer are "cases"

Plasma concentration of choline

Intervention Type OTHER

The exposure in this observational study is plasma concentrations of choline

Benign hyperplasia

Men participants diagnosed with benign hyperplasia are the "controls"

Plasma concentration of choline

Intervention Type OTHER

The exposure in this observational study is plasma concentrations of choline

Interventions

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Plasma concentration of choline

The exposure in this observational study is plasma concentrations of choline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men participants
* age \> 50 years
* recently diagnosed with primary prostate cancer or benign hyperplasia

Exclusion Criteria

* vitamin B supplementation (folic acid\> 400 µg / day; B12\> 10 µg / day; B6\> 10 mg / day)
* renal failure
* advanced liver disease
* chronic alcohol consumption
* metastases
* methotrexate therapy.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Rima Obeid

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rima Obeid, PhD

Role: PRINCIPAL_INVESTIGATOR

Saarland University Hospital

Locations

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University of Saarland

Homburg, Saarland, Germany

Site Status

Countries

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Germany

References

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Awwad HM, Ohlmann CH, Stoeckle M, Aziz R, Geisel J, Obeid R. Choline-phospholipids inter-conversion is altered in elderly patients with prostate cancer. Biochimie. 2016 Jul;126:108-14. doi: 10.1016/j.biochi.2016.01.003. Epub 2016 Jan 14.

Reference Type RESULT
PMID: 26776756 (View on PubMed)

Awwad HM, Ohlmann CH, Stoeckle M, Geisel J, Obeid R. Serum concentrations of folate vitamers in patients with a newly diagnosed prostate cancer or hyperplasia. Clin Biochem. 2018 Jun;56:41-46. doi: 10.1016/j.clinbiochem.2018.04.011. Epub 2018 Apr 16.

Reference Type RESULT
PMID: 29673813 (View on PubMed)

Other Identifiers

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Choline Prostate Cancer

Identifier Type: -

Identifier Source: org_study_id

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