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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06380062
Enrollment
350
Registered
2024-04-23
Start date
2012-01-12
Completion date
2015-11-30
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Primary Prostate Urothelial Cancer

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.

Interventions

OTHERPlasma concentration of choline

The exposure in this observational study is plasma concentrations of choline

Sponsors

Universität des Saarlandes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma choline concentrationsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry
Whole blood choline concentrationsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry

Secondary

MeasureTime frameDescription
Plasma S-adenosylmethionine concentrationsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma betaine concentrationsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma and whole blood folate formsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma homocysteine concentrationsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry
Plasma methylmalonic acid concentrationsthrough study completion, on average 1 yearConcentrations measured in plasma with gas chromatography mass spectrometry
Plasma phospholipidsthrough study completion, on average 1 yearConcentrations measured in plasma with liquid chromatography tandem mass spectrometry after extraction

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026