Clinical trial NCT06726070: Investigation of the Diagnostic Role of miRNAs in PCa and BPH
Official title: Investigation of Candidate miRNAs as Potential Biomarkers in the Early Diagnosis of Prostate Cancer and Benign Prostate Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostate Hypertrophy(BPH)
Prostate Cancer (Adenocarcinoma)
Keywords: prostate cancer
Benign Prostate Hypertrophy(BPH)
miRNA
biomarker
PSA
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 57
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients applying to the Urology Clinic of Alanya Alaaddin Keykubat University Training and Research Hospital.

Brief summary: Prostate cancer(PCa) is the second most common cause of cancer-related death in men after lung cancer. Diagnostic methods such as measurement of serum Prostate-specific antigen (PSA) levels used in the clinic still cannot distinguish between benign conditions and prostate cancer, and biopsy is essential for the diagnosis of prostate cancer. Due to the high false-positive rate of PSA, many patients are accidentally biopsied, which carries various risks for patients. Therefore, there is a need for new diagnostic methods to support PSA and the identification of reliable biomarkers for early diagnosis.

microRNAs (miRNAs) are short non-coding RNAs that can be detected in body fluids such as urine, blood and serum. In recent years, miRNAs have been nominated as reliable biomarkers that help us make an accurate diagnosis in many diseases, such as cancer. Although various miRNAs have been detected in the sera of prostate cancer patients, there is still little data on which miRNAs can be used as biomarkers.

In this study, investigators aimed to evaluate the expression levels of miR-107, miR-134-5p, miR-149-5p, miR-370-3p and miR-221 in blood as biomarkers capable of distinguishing PCa from benign prostatic hyperplasia (BPH) and will prevent unnecessary biopsies. In addition, they aimed to compare some clinical features such as serum PSA and Gleason Score with serum miRNA levels and determine the relationship between them.

Detailed description: The present study is a prospective study and consists of three work packages. First, clinical evaluations were made and biopsy samples were taken from patients who applied to the urology clinic, had serum PSA levels higher than 4 ng/ML, and were suspected of prostate cancer. Then, a pathological examination of the biopsy samples was performed and the patients were grouped into PCA and BPH. Finally, molecular analyses were performed on blood samples obtained from patients and healthy controls and all obtained data were statistically evaluated.

Eligibility criteria: Inclusion Criteria:

* For all groups, between 40-70 years of age.
* Prostate cancer group: Patients with positive digital rectal examination (DRE) results, serum PSA level above 4 ng/mL and a confirmed pathological diagnosis of Prostate cancer.
* BPH group: Patients with a PSA level over 4 ng/mL and a negative DRE result who were clinically and pathologically diagnosed with BPH.
* Control: Healthy volunteers who applied to the urology outpatient clinic for routine check-ups and whose PSA value was below 4 ng/ml.

Exclusion Criteria:

* To have undergone drug therapy or surgery for prostate cancer,
* To have chronic inflammatory or infectious diseases,
* Were hospitalized within the past year for a chronic illness,
* To have another known malignancy,
* Being outside the age limit of 40-70.

Primary outcomes:
measure: Evaluation of miRNA expressions
timeFrame: March 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaaddin Keykubat University Training and Research Hospital
Study officials:
affiliation: Alanya Alaaddin Keykubat University
name: Ali AKKOÇ
role: STUDY_CHAIR
References:
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