Clinical trial NCT06380062: Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia
Official title: Pre-operative Plasma Concentrations of Choline and Its Metabolites in People With Prostate Cancer Compared to Those With Benign Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Prostate Urothelial Cancer
Benign Prostatic Hyperplasia
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 350
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were recruited before carrying out the radical prostatectomy surgery, or TURP surgery.

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.

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.

Primary outcomes:
measure: Plasma choline concentrations
timeFrame: through study completion, on average 1 year
measure: Whole blood choline concentrations
timeFrame: through study completion, on average 1 year
Secondary outcomes:
measure: Plasma and whole blood folate forms
timeFrame: through study completion, on average 1 year
measure: Plasma phospholipids
timeFrame: through study completion, on average 1 year
measure: Plasma S-adenosylmethionine concentrations
timeFrame: through study completion, on average 1 year
measure: Plasma betaine concentrations
timeFrame: through study completion, on average 1 year
measure: Plasma methylmalonic acid concentrations
timeFrame: through study completion, on average 1 year
measure: Plasma homocysteine concentrations
timeFrame: through study completion, on average 1 year
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saarland
state: Saarland
Study officials:
affiliation: Saarland University Hospital
name: Rima Obeid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.