Benign Prostate Hypertrophy(BPH)NCT06726070
Investigation of the Diagnostic Role of miRNAs in PCa and BPH
An observational study of Benign Prostate Hypertrophy(BPH) and Prostate Cancer (Adenocarcinoma), run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), Prostate Cancer (Adenocarcinoma)
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 2 Mar 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients applying to the Urology Clinic of Alanya Alaaddin Keykubat University Training and Research Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University Training and Research Hospital
Antalya, 07400
About this study
Official title: Investigation of Candidate miRNAs as Potential Biomarkers in the Early Diagnosis of Prostate Cancer and Benign Prostate Hyperplasia
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.
Read the 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.
- Keywords
- prostate cancer, Benign Prostate Hypertrophy(BPH), miRNA, biomarker, PSA
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Prostate Cancer Patients | |
| Benign Prostatic Hyperplasia | Benign prostatic hyperplasia(BPH) patients | |
| Control | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jun 2020
- Primary completion5 Dec 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKKOC, Alanya Alaaddin Keykubat University
- Investigators
- Ali AKKOÇ, Study chair, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726070
- Sponsor's protocol ID
- 10354421-2020/16-24
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39311384Shao 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.
PubMed 29506516Su 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.
PubMed 28454346Pelka 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.
PubMed 33331954Chen 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.
PubMed 27573045Nayak 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.
PubMed 32213205Foj 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.
PubMed 27990656Vanacore 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.
PubMed 28445135
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Candidate miRNAs as Potential Biomarkers in the Early Diagnosis of Prostate Cancer and Benign Prostate Hyperplasia
- ClinicalTrials.gov ID
- NCT06726070
- Acronym / sponsor ID
- 10354421-2020/16-24
- Keywords
- prostate cancer, Benign Prostate Hypertrophy(BPH), miRNA, biomarker, PSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | –Prostate Cancer Patients |
| Benign Prostatic Hyperplasia | – | –Benign prostatic hyperplasia(BPH) patients |
| Control | – | –Healthy control |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients applying to the Urology Clinic of Alanya Alaaddin Keykubat University Training and Research Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of miRNA expressions
Time frame: March 2023
Five different miRNAs will be evaluated in the study: miR-107, miR-134-5p, miR-149-5p, miR-370-3p and miR-221
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 39311384Puente-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.
- Background: PubMed 29506516Shao 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.
- Background: PubMed 28454346Su 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.
- Background: PubMed 33331954Pelka 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.
- Background: PubMed 27573045Chen 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.
- Background: PubMed 32213205Nayak 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.
- Background: PubMed 27990656Foj 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.
- Background: PubMed 28445135Vanacore 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali AKKOÇ study chair
Alanya Alaaddin Keykubat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hypertrophy(BPH) and Prostate Cancer (Adenocarcinoma), run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of miRNA expressions (time frame: March 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06726070, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.