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Completed

NCT Number: NCT06380062

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Saarland

Homburg, Saarland, 66424, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma concentration of choline

Other

The exposure in this observational study is plasma concentrations of choline

Primary outcomes

  1. Plasma choline concentrations

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

  2. 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

  1. Plasma and whole blood folate forms

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

  2. Plasma phospholipids

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with liquid chromatography tandem mass spectrometry after extraction

  3. Plasma S-adenosylmethionine concentrations

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

  4. Plasma betaine concentrations

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

  5. Plasma methylmalonic acid concentrations

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with gas chromatography mass spectrometry

  6. Plasma homocysteine concentrations

    Time frame: through study completion, on average 1 year

    Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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