NCT06726070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

November 16, 2024

Last Update Submit

December 5, 2024

Conditions

Benign Prostate Hypertrophy(BPH)Prostate Cancer (Adenocarcinoma)

Keywords

prostate cancerBenign Prostate Hypertrophy(BPH)miRNAbiomarkerPSA

Outcome Measures

Primary Outcomes (1)

  • Evaluation of miRNA expressions

    Five different miRNAs will be evaluated in the study: miR-107, miR-134-5p, miR-149-5p, miR-370-3p and miR-221

    March 2023

Study Arms (3)

Prostate Cancer

Prostate Cancer Patients

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia(BPH) patients

Control

Healthy control

Eligibility Criteria

Age40 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSince the study was about prostate cancer, only male patients were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients applying to the Urology Clinic of Alanya Alaaddin Keykubat University Training and Research Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University Training and Research Hospital

Antalya, 07400, Turkey (Türkiye)

Location

Related Publications (8)

  • Puente-Rivera J, De la Rosa Perez DA, Olvera SIN, Figueroa-Angulo EE, Saucedo JGC, Hernandez-Leon O, Alvarez-Sanchez ME. The Circulating miR-107 as a Potential Biomarker Up-Regulated in Castration-Resistant Prostate Cancer. Noncoding RNA. 2024 Aug 24;10(5):47. doi: 10.3390/ncrna10050047.

    PMID: 39311384BACKGROUND

  • Shao N, Ma G, Zhang J, Zhu W. miR-221-5p enhances cell proliferation and metastasis through post-transcriptional regulation of SOCS1 in human prostate cancer. BMC Urol. 2018 Mar 5;18(1):14. doi: 10.1186/s12894-018-0325-8.

    PMID: 29506516BACKGROUND

  • Su X, Zhang L, Li H, Cheng P, Zhu Y, Liu Z, Zhao Y, Xu H, Li D, Gao H, Zhang T. MicroRNA-134 targets KRAS to suppress breast cancer cell proliferation, migration and invasion. Oncol Lett. 2017 Mar;13(3):1932-1938. doi: 10.3892/ol.2017.5644. Epub 2017 Jan 25.

    PMID: 28454346BACKGROUND

  • Pelka K, Klicka K, Grzywa TM, Gondek A, Marczewska JM, Garbicz F, Szczepaniak K, Paskal W, Wlodarski PK. miR-96-5p, miR-134-5p, miR-181b-5p and miR-200b-3p heterogenous expression in sites of prostate cancer versus benign prostate hyperplasia-archival samples study. Histochem Cell Biol. 2021 Mar;155(3):423-433. doi: 10.1007/s00418-020-01941-2. Epub 2020 Dec 17.

    PMID: 33331954BACKGROUND

  • Chen Y, Zhao J, Luo Y, Wang Y, Jiang Y. Downregulated expression of miRNA-149 promotes apoptosis in side population cells sorted from the TSU prostate cancer cell line. Oncol Rep. 2016 Nov;36(5):2587-2600. doi: 10.3892/or.2016.5047. Epub 2016 Aug 25.

    PMID: 27573045BACKGROUND

  • Nayak B, Khan N, Garg H, Rustagi Y, Singh P, Seth A, Dinda AK, Kaushal S. Role of miRNA-182 and miRNA-187 as potential biomarkers in prostate cancer and its correlation with the staging of prostate cancer. Int Braz J Urol. 2020 Jul-Aug;46(4):614-623. doi: 10.1590/S1677-5538.IBJU.2019.0409.

    PMID: 32213205BACKGROUND

  • Foj L, Ferrer F, Serra M, Arevalo A, Gavagnach M, Gimenez N, Filella X. Exosomal and Non-Exosomal Urinary miRNAs in Prostate Cancer Detection and Prognosis. Prostate. 2017 May;77(6):573-583. doi: 10.1002/pros.23295. Epub 2016 Dec 19.

    PMID: 27990656BACKGROUND

  • Vanacore D, Boccellino M, Rossetti S, Cavaliere C, D'Aniello C, Di Franco R, Romano FJ, Montanari M, La Mantia E, Piscitelli R, Nocerino F, Cappuccio F, Grimaldi G, Izzo A, Castaldo L, Pepe MF, Malzone MG, Iovane G, Ametrano G, Stiuso P, Quagliuolo L, Barberio D, Perdona S, Muto P, Montella M, Maiolino P, Veneziani BM, Botti G, Caraglia M, Facchini G. Micrornas in prostate cancer: an overview. Oncotarget. 2017 Jul 25;8(30):50240-50251. doi: 10.18632/oncotarget.16933.

    PMID: 28445135BACKGROUND

MeSH Terms

Conditions

Prostatic HyperplasiaProstatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Ali AKKOÇ

    Alanya Alaaddin Keykubat University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

November 16, 2024

First Posted

December 10, 2024

Study Start

June 1, 2020

Primary Completion

December 5, 2022

Study Completion

March 2, 2023

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

The study included 20 PCa and 17 BPH patients who were clinically and pathologically confirmed, aged between 40 and 70, and had serum PSA levels above 4 ng/mL. Additionally, 20 healthy volunteers were included in the study as the control group. The clinical diagnosis of patients included in the study was conducted at the University Training and Research Hospital Urology Outpatient Clinic, with pathological assessments performed in the Pathology Laboratory. miRNA expression analyses were performed using quantitative real-time polymerase chain reaction (qRT- PCR) in peripheral blood samples. All statistical analyses were performed using GraphPad Prism-5 (ver.9.0). Analyses were performed using the Kruskal-Wallis rank or Mann Whitney-U test and Spearman's test was used for correlation analysis. The role of miRNAs as biomarkers in PCa was investigated by drawing the receiver operating characteristic (ROC) curves. Statistical significance was taken as p \<0.05.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Ethical approval: 13.02.2020; Project start and completion: 01.06.2020-02.03.2023; Patient registration start and completion: 26.01.2021-05.12.2022; The project duration lasted 2 years and 9 months in total.
Access Criteria
IPD and any additional supporting information can be shared with investigators who write about Prostate cancer.

Locations

TU(1)