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Clinical Trials/NCT06380062
NCT06380062
Completed
Not Applicable

Pre-operative Plasma Concentrations of Choline and Its Metabolites in People With Prostate Cancer Compared to Those With Benign Hyperplasia

Universität des Saarlandes1 site in 1 country350 target enrollmentJanuary 12, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Prostate Urothelial Cancer
Sponsor
Universität des Saarlandes
Enrollment
350
Locations
1
Primary Endpoint
Plasma choline concentrations
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2012
End Date
November 30, 2015
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rima Obeid

Prof. Dr.

Universität des Saarlandes

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Plasma choline concentrations

Time Frame: through study completion, on average 1 year

Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

Whole blood choline concentrations

Time Frame: through study completion, on average 1 year

Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

Secondary Outcomes

  • Plasma homocysteine concentrations(through study completion, on average 1 year)
  • Plasma phospholipids(through study completion, on average 1 year)
  • Plasma betaine concentrations(through study completion, on average 1 year)
  • Plasma methylmalonic acid concentrations(through study completion, on average 1 year)
  • Plasma and whole blood folate forms(through study completion, on average 1 year)
  • Plasma S-adenosylmethionine concentrations(through study completion, on average 1 year)

Study Sites (1)

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