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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06380062
• Other study ID #: Choline Prostate Cancer
• Status: Completed
• Start date: January 12, 2012
• Est. completion date: November 30, 2015

Study information

• Verified date: April 2024
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Other:
• Plasma concentration of choline
The exposure in this observational study is plasma concentrations of choline

Locations

Country	Name	City	State
Germany	University of Saarland	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma choline concentrations	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry	through study completion, on average 1 year
Primary	Whole blood choline concentrations	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry	through study completion, on average 1 year
Secondary	Plasma and whole blood folate forms	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry	through study completion, on average 1 year
Secondary	Plasma phospholipids	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry after extraction	through study completion, on average 1 year
Secondary	Plasma S-adenosylmethionine concentrations	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry	through study completion, on average 1 year
Secondary	Plasma betaine concentrations	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry	through study completion, on average 1 year
Secondary	Plasma methylmalonic acid concentrations	Concentrations measured in plasma with gas chromatography mass spectrometry	through study completion, on average 1 year
Secondary	Plasma homocysteine concentrations	Concentrations measured in plasma with liquid chromatography tandem mass spectrometry	through study completion, on average 1 year