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

Completed

• Conditions: Primary Prostate Urothelial Cancer; Benign Prostatic Hyperplasia
• Interventions: Other: Plasma concentration of choline

• Registration Number: NCT06380062
• Lead Sponsor: Universität des Saarlandes

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.

Study Timeline

• Study Start: 2012-01-12
• Primary Completion: 2015-11-30
• Study Completion: 2015-11-30
• Study First Submitted: 2023-05-02
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-23
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign hyperplasia	Plasma concentration of choline	Men participants diagnosed with benign hyperplasia are the "controls"
Primary prostate cancer	Plasma concentration of choline	Men participants diagnosed with primary prostate cancer are "cases"

Primary Outcome Measures

Name	Time	Method
Plasma choline concentrations	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Whole blood choline concentrations	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

Secondary Outcome Measures

Name	Time	Method
Plasma homocysteine concentrations	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma phospholipids	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry after extraction
Plasma betaine concentrations	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma methylmalonic acid concentrations	through study completion, on average 1 year	Concentrations measured in plasma with gas chromatography mass spectrometry
Plasma S-adenosylmethionine concentrations	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma and whole blood folate forms	through study completion, on average 1 year	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

Trial Locations

Locations (1)

University of Saarland; 🇩🇪 Homburg, Saarland, Germany