Prostate CancerNCT03936296
Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and MR-guided Fusion Transrectal Prostate Biopsy
A study testing mpMR guided MR-US fusion transrectal prostate biopsy and 12 core standard transrectal prostate biopsy in people with Prostate Cancer, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Prostate cancer is the most frequent cancer in men. Today serum prostate specific antigen (PSA) level and digital rectal examination (DRE) are routinely used for screening of prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mpMR guided MR-US fusion transrectal prostate biopsy and 12 core standard transrectal prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2017to 28 Aug 2020
- Phase
- Interventional
- 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSA level 2,5-10mg/dl Approving the transrectal prostate biopsy and mpMR NO contraindication for MR: glomerular filtration rate (GFR) >60ml/dk, no claustrophobia, no prosthesis or cardiac pacemaker which is not suitable for MR no contraindication for stopping antiaggregant or antithrombotic treatment. no history of previous prostate biopsy no diagnosis of prostate cancer or other malignancies
Who cannot join
- not approving the biopsy and MR imaging
- having prosthesis or cardiac pace maker not suitable for MR
- having contraindication for stopping antiaggregant or antithrombotic treatment.
- history of previous prostate biopsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, 38039
About this study
Official title: Comparison of Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and Multiparametric Prostate MR Guided MR-US Fusion Transrectal Prostate Biopsy
Prostate cancer is the most frequent cancer in men. Today serum prostate specific antigen (PSA) level and digital rectal examination (DRE) are routinely used for screening of prostate cancer. In the case of higher PSA levels and/or abnormal DRE, 10-12 core standard transrectal prostate biopsy (STRUS-B) is preferred method.Most of the pathological T1 stage tumours are diagnosed by this method. But as the prostate volume increases, cancer detection rate of STRUS-B decreases.In the last decade multiparametric prostate magnetic resonance imaging (mpMR) has gained importance in the diagnosis of prostate cancer beside the staging. Now it is possible to biopsies from lesions which are suspicious for cancer in mpMR. Recent studies have shown that mpMR guided prostate biopsies either transrectally or perineally have better cancer detection rates comparing STRUS-B, especially in patients with history of negative previous biopsy. But its use in biopsy naive settings is not recommended.In this study it is aimed to compare cancer detection rate of MR guided MR-US fusion transrectal prostate biopsy with STRUS-B.
Read the detailed description
A histopathological evaluation of STRUS-B materials based on suspicious DRE findings and high or increasing PSA levels is the gold standard in prostate cancer diagnosis. However, the fact that approximately one-third of malignant prostate lesions is isoechoic and cannot be detected using conventional grayscale transrectal ultrasonography (TRUS) decreases the sensitivity rates of STRUS-B. These restrictions on the use of TRUS have encouraged urologists to use new methods to diagnose prostate cancer. One of these methods is the biopsy of lesions defined using mpMR, which has been widely used for the past 10 years. An MR targeted biopsy can be performed cognitively under MR guidance or using ultrasound devices with fusion software that can combine MR images with sonographic images. mpMR targeted biopsies are recommended in the current clinical practice for re-biopsies of patients who had previous negative biopsy but clinically suspected of cancer, follow-up biopsies of active surveillance, and biopsies of patients who are suspected to have recurrence after local minimally invasive treatment, such as radiotherapy and high-intensity focused ultrasonography. Recent studies showed that the cancer detection rate of mpMRIguided prostate biopsy is between 33.7% and 79.5%, which is higher than that of standard 12-core transrectal biopsy. However, the number of studies evaluating the use of MR targeted prostate biopsy in biopsy naive patients is limited.
In this study it is aimed to compare cancer detection rates of STRUS-B and MR guided MR-US fusion transrectal prostate biopsy in the biopsy naive patient setting.
100 patients will be randomized to STRUS-B arm and another 100 to fusion arm. In the standard arm patients who have high PSA levels and/or suspicious DRE will be undertaken STRUS-B. In the study arm all patients will undergo a multiparametric prostate MR without endorectal coils. MRI will be performed by Siemens Magnetom(Trade mark) 1.5 T (Siemens Medical Solutions, Pennsylvania, USA) MRI system. The images wi,ll be reviewed by an experienced uro-radiologist who has no detailed clinical information about the patients. Suspected areas in T2, T1 contrast, and diffusion-weighted images of multiparametric MRI were reported according to Prostate Imaging Reporting and Data System Version-2 (PIRADS v2). In cases of multiple lesions with different PIRADS scores, the lesion with the highest PIRADS score will be accepted as dominant lesion. Biopsy procedures will be performed under local anesthesia or sedoanalgesia. However, sedoanalgesia will be preferred if the patient could not tolerate pain during the penetration of US probe due to low pain threshold or anal canal stricture due to previous rectal surgeries. The procedure will be performed in outpatient clinic conditions. Transrectal ultrasonography will be performed by using an ultrasonography system with rigid fusion software (LOGIQ E9; General Electric, Massachusetts, USA) when patients lie on the left decubitus position. Rectal lidocaine gel will be applied 5 min before rectal US probe is introduced. A sonographic examination of the prostate tissue will be performed to check the presence of prominent lesions. Total prostate volumes will be measured. Multiparametric prostate MRI images will be uploaded to the US system on the day of biopsy. After segmentation (matching) of MRI images with sonographic images, the lesions reported in mpMR will be marked. The periprostatic block will be then performed with 2% prilocaine hydrochloride (20 mg/mL) injected into the neurovascular bundle on both sides of the prostate, with 5 mL to the right and 5 mL to the left. Following the block, two to five core biopsies from the MRI-targeted lesions with PIRADS ≥3 will be obtained. All procedures in fusion biopsy will be performed by two urologists experienced and trained in transrectal prostate ultrasonography and biopsy. After the F-TRUS biopsy completed, a standard 12-core TRUS biopsy will performed on fusion group. STRUS_B arm only standard 12 core transrectal prostate biopsy will be performed. A histopathological evaluation of biopsy specimens will be performed by a uro-pathologist with >10 years of experience. The percentage of cancer within the core, primary, and secondary Gleason score and grade according to the 2014 International Society of Urological Pathology (ISUP) grade will be specified in the final pathology report. Patients reported with high-grade prostatic intraepithelial neoplasm in three or more cores or atypical small acinar proliferation will be redirected to rebiopsy, but they will be included to the benign group in the evaluation of the present study.
As the secondary outcomes, pain level during MR fusion biopsy and STRUS biopsy evaluated by visual analogue scale score, cancer detection rates of different core numbers taken form MR targeted lesion, role of the peripheric blood parameters (such as, neutrophil to lymphocyte ratio and systemic immune inflammatuary index) in predicting prostate cancer in PRIADS 3,4 and 5lesions, and comparison of the tumor laterality and ISUP grade in MR US fuison biopsy and radical prostatectomy specimens will be evaluated.
- Conditions
- Prostate Cancer
- Being tested
- mpMR guided MR-US fusion transrectal prostate biopsy, 12 core standard transrectal prostate biopsy
- Keywords
- multiparametric prostate magnetic resonance imaging, MR-US fusion, MR guided prostate biopsy, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMR guided MR-US fusion transrectal prostate biopsyProcedure or surgery
Also called Fusion biopsy
mpMR images will be loaded to US fusion platform and registration of the will be performed. Suspicious lesions on MR which have PIRADS score 3 and above are targeted. Additional 2-4 cores biopsies will be taken them
12 core standard transrectal prostate biopsyProcedure or surgery
Also called STRUS-B
Under the guidance of transrectal ultrasonography, 12 core biopsies taken from apex, apex lateral, mid, mid lateral, base and base lateral of right and left prostate lobe
| Study group | Role | What they receive |
|---|---|---|
| fusion arm | Active comparator | Patients in this arm will be undertaken standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy Receives: Procedure: mpMR guided MR-US fusion transrectal prostate biopsy |
| Standard arm | Other | Patients in this arm will be undertaken only standard transrectal prostate biopsy Receives: Procedure: 12 core standard transrectal prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer detection rate of MR-US fusion biopsies
percentage of prostate cancer detected by fusion biopsies
Measured: 15 days after biopsy
clinically significant cancer detection rate of MR-US fusion biopsies
percentage of prostate cancer which is ISUP group 2 and above detected by fusion biopsies
Measured: 15 days after biopsy
cancer detection rate of STRUS-B
percentage of prostate cancer detected by STRUS-B
Measured: 15 days after biopsy
clinically significant cancer detection rate of STRUS-B
percentage of prostate cancer which is ISUP group 2 and above detected by STRUS-B
Measured: 15 days after biopsy
cancer detection rate of combined method (fusion + STRUS-B )
percentage of prostate cancer detected by combined method
Measured: 15 days after biopsy
clinically significant cancer detection rate of combined method (fusion + STRUS-B )
percentage of prostate cancer which is ISUP group 2 and above detected by combined method
Measured: 15 days after biopsy
Secondary outcomes (6)
Visual analogue Scale score for pain
To score the pain level that expreinced by patients during STRUS-B and MR-US bx
Measured: Just after the biopsy
Comparison of the cancer detection rate of different core numbers taken from MR lesion.
Cancer detection rate of the 2, 3 and 4 cores taken from PIRADS 3,4 and 5 lesion
Measured: 15 days after biopsy
Neutrophil to lymphocyte ratio to predict cancer in different PRIADS lesions.
Neutrophil to lymphocyte ratio to predict cancer in different PRIADS lesions.
Measured: 15 days after biopsy
Role of Systemic immune-infllamatuary index to predict the caner in PIRADS 3,4 5 lesions
neutrophil x platelet count /lymphocyte count
Measured: 15 days after biopsy
Tumor upgrade rate of MR US fusion biopsy in radical prostatectomy specimens
comparison of the ISUP grade of MR-fusion biopsy and radical prostatectomy speimens at whom underwent radical prostatectomy
Measured: 15 days after radical prosatetctomy
Tumor laterality in biopsy specimens and radical prostatectomy specimens
Tumor laterality in biopsy specimens and radical prostatectomy specimens
Measured: 15 days after radical prosatetctomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start6 Dec 2017
- Primary completion30 Jun 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To perform standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy in the 2 randomized patient group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Demirtas, TC Erciyes University
- Investigators
- Abdullah Demritas, Assoc Prof, Principal investigator, Erciyes University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936296
- Sponsor's protocol ID
- TSG-2016-5200
- Status last verified
- Aug 2020
- First submitted
- 30 Apr 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durmus T, Baur A, Hamm B. Multiparametric magnetic resonance imaging in the detection of prostate cancer. Aktuelle Urol. 2014 Mar;45(2):119-26. doi: 10.1055/s-0034-1371875. Epub 2014 Apr 3.
PubMed 24700068Hong CW, Amalou H, Xu S, Turkbey B, Yan P, Kruecker J, Pinto PA, Choyke PL, Wood BJ. Prostate biopsy for the interventional radiologist. J Vasc Interv Radiol. 2014 May;25(5):675-84. doi: 10.1016/j.jvir.2013.12.568. Epub 2014 Feb 26.
PubMed 24581731Liao S, Gao Y, Oto A, Shen D. Representation learning: a unified deep learning framework for automatic prostate MR segmentation. Med Image Comput Comput Assist Interv. 2013;16(Pt 2):254-61. doi: 10.1007/978-3-642-40763-5_32.
PubMed 24579148Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530.
PubMed 26492179Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.
PubMed 26361169Kuru TH, Roethke MC, Seidenader J, Simpfendorfer T, Boxler S, Alammar K, Rieker P, Popeneciu VI, Roth W, Pahernik S, Schlemmer HP, Hohenfellner M, Hadaschik BA. Critical evaluation of magnetic resonance imaging targeted, transrectal ultrasound guided transperineal fusion biopsy for detection of prostate cancer. J Urol. 2013 Oct;190(4):1380-6. doi: 10.1016/j.juro.2013.04.043. Epub 2013 Apr 19.
PubMed 23608676Pokorny MR, de Rooij M, Duncan E, Schroder FH, Parkinson R, Barentsz JO, Thompson LC. Prospective study of diagnostic accuracy comparing prostate cancer detection by transrectal ultrasound-guided biopsy versus magnetic resonance (MR) imaging with subsequent MR-guided biopsy in men without previous prostate biopsies. Eur Urol. 2014 Jul;66(1):22-9. doi: 10.1016/j.eururo.2014.03.002. Epub 2014 Mar 14.
PubMed 24666839Junker D, Schafer G, Heidegger I, Bektic J, Ladurner M, Jaschke W, Aigner F. Multiparametric magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy of the prostate: preliminary results of a prospective single-centre study. Urol Int. 2015;94(3):313-8. doi: 10.1159/000365489. Epub 2015 Jan 9.
PubMed 25591786Abd-Alazeez M, Kirkham A, Ahmed HU, Arya M, Anastasiadis E, Charman SC, Freeman A, Emberton M. Performance of multiparametric MRI in men at risk of prostate cancer before the first biopsy: a paired validating cohort study using template prostate mapping biopsies as the reference standard. Prostate Cancer Prostatic Dis. 2014 Mar;17(1):40-6. doi: 10.1038/pcan.2013.43. Epub 2013 Oct 15.
PubMed 24126797Delongchamps NB, Peyromaure M, Schull A, Beuvon F, Bouazza N, Flam T, Zerbib M, Muradyan N, Legman P, Cornud F. Prebiopsy magnetic resonance imaging and prostate cancer detection: comparison of random and targeted biopsies. J Urol. 2013 Feb;189(2):493-9. doi: 10.1016/j.juro.2012.08.195. Epub 2012 Oct 8.
PubMed 22982424Sonmez G, Demirtas T, Tombul ST, Ozturk F, Demirtas A. What is the ideal number of biopsy cores per lesion in targeted prostate biopsy? Prostate Int. 2020 Sep;8(3):112-115. doi: 10.1016/j.prnil.2020.03.004. Epub 2020 Apr 23.
PubMed 33102391
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and Multiparametric Prostate MR Guided MR-US Fusion Transrectal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT03936296
- Acronym / sponsor ID
- TSG-2016-5200
- Conditions
- Prostate Cancer
- Keywords
- multiparametric prostate magnetic resonance imaging, MR-US fusion, MR guided prostate biopsy, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 3 May 2019 (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 is the most frequent cancer in men. Today serum prostate specific antigen (PSA) level and digital rectal examination (DRE) are routinely used for screening of prostate cancer. In the case of higher PSA levels and/or abnormal DRE, 10-12 core standard transrectal prostate biopsy (STRUS-B) is preferred method.Most of the pathological T1 stage tumours are diagnosed by this method. But as the prostate volume increases, cancer detection rate of STRUS-B decreases.In the last decade multiparametric prostate magnetic resonance imaging (mpMR) has gained importance in the diagnosis of prostate cancer beside the staging. Now it is possible to biopsies from lesions which are suspicious for cancer in mpMR. Recent studies have shown that mpMR guided prostate biopsies either transrectally or perineally have better cancer detection rates comparing STRUS-B, especially in patients with history of negative previous biopsy. But its use in biopsy naive settings is not recommended.In this study it is aimed to compare cancer detection rate of MR guided MR-US fusion transrectal prostate biopsy with STRUS-B.
Detailed description
A histopathological evaluation of STRUS-B materials based on suspicious DRE findings and high or increasing PSA levels is the gold standard in prostate cancer diagnosis. However, the fact that approximately one-third of malignant prostate lesions is isoechoic and cannot be detected using conventional grayscale transrectal ultrasonography (TRUS) decreases the sensitivity rates of STRUS-B. These restrictions on the use of TRUS have encouraged urologists to use new methods to diagnose prostate cancer. One of these methods is the biopsy of lesions defined using mpMR, which has been widely used for the past 10 years. An MR targeted biopsy can be performed cognitively under MR guidance or using ultrasound devices with fusion software that can combine MR images with sonographic images. mpMR targeted biopsies are recommended in the current clinical practice for re-biopsies of patients who had previous negative biopsy but clinically suspected of cancer, follow-up biopsies of active surveillance, and biopsies of patients who are suspected to have recurrence after local minimally invasive treatment, such as radiotherapy and high-intensity focused ultrasonography. Recent studies showed that the cancer detection rate of mpMRIguided prostate biopsy is between 33.7% and 79.5%, which is higher than that of standard 12-core transrectal biopsy. However, the number of studies evaluating the use of MR targeted prostate biopsy in biopsy naive patients is limited.
In this study it is aimed to compare cancer detection rates of STRUS-B and MR guided MR-US fusion transrectal prostate biopsy in the biopsy naive patient setting.
100 patients will be randomized to STRUS-B arm and another 100 to fusion arm. In the standard arm patients who have high PSA levels and/or suspicious DRE will be undertaken STRUS-B. In the study arm all patients will undergo a multiparametric prostate MR without endorectal coils. MRI will be performed by Siemens Magnetom(Trade mark) 1.5 T (Siemens Medical Solutions, Pennsylvania, USA) MRI system. The images wi,ll be reviewed by an experienced uro-radiologist who has no detailed clinical information about the patients. Suspected areas in T2, T1 contrast, and diffusion-weighted images of multiparametric MRI were reported according to Prostate Imaging Reporting and Data System Version-2 (PIRADS v2). In cases of multiple lesions with different PIRADS scores, the lesion with the highest PIRADS score will be accepted as dominant lesion. Biopsy procedures will be performed under local anesthesia or sedoanalgesia. However, sedoanalgesia will be preferred if the patient could not tolerate pain during the penetration of US probe due to low pain threshold or anal canal stricture due to previous rectal surgeries. The procedure will be performed in outpatient clinic conditions. Transrectal ultrasonography will be performed by using an ultrasonography system with rigid fusion software (LOGIQ E9; General Electric, Massachusetts, USA) when patients lie on the left decubitus position. Rectal lidocaine gel will be applied 5 min before rectal US probe is introduced. A sonographic examination of the prostate tissue will be performed to check the presence of prominent lesions. Total prostate volumes will be measured. Multiparametric prostate MRI images will be uploaded to the US system on the day of biopsy. After segmentation (matching) of MRI images with sonographic images, the lesions reported in mpMR will be marked. The periprostatic block will be then performed with 2% prilocaine hydrochloride (20 mg/mL) injected into the neurovascular bundle on both sides of the prostate, with 5 mL to the right and 5 mL to the left. Following the block, two to five core biopsies from the MRI-targeted lesions with PIRADS ≥3 will be obtained. All procedures in fusion biopsy will be performed by two urologists experienced and trained in transrectal prostate ultrasonography and biopsy. After the F-TRUS biopsy completed, a standard 12-core TRUS biopsy will performed on fusion group. STRUS_B arm only standard 12 core transrectal prostate biopsy will be performed. A histopathological evaluation of biopsy specimens will be performed by a uro-pathologist with >10 years of experience. The percentage of cancer within the core, primary, and secondary Gleason score and grade according to the 2014 International Society of Urological Pathology (ISUP) grade will be specified in the final pathology report. Patients reported with high-grade prostatic intraepithelial neoplasm in three or more cores or atypical small acinar proliferation will be redirected to rebiopsy, but they will be included to the benign group in the evaluation of the present study.
As the secondary outcomes, pain level during MR fusion biopsy and STRUS biopsy evaluated by visual analogue scale score, cancer detection rates of different core numbers taken form MR targeted lesion, role of the peripheric blood parameters (such as, neutrophil to lymphocyte ratio and systemic immune inflammatuary index) in predicting prostate cancer in PRIADS 3,4 and 5lesions, and comparison of the tumor laterality and ISUP grade in MR US fuison biopsy and radical prostatectomy specimens will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To perform standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy in the 2 randomized patient group
| Arm | Type | Receives |
|---|---|---|
| fusion arm | Active comparator | Procedure: mpMR guided MR-US fusion transrectal prostate biopsyPatients in this arm will be undertaken standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy |
| Standard arm | Other | Procedure: 12 core standard transrectal prostate biopsyPatients in this arm will be undertaken only standard transrectal prostate biopsy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PSA level 2,5-10mg/dl Approving the transrectal prostate biopsy and mpMR NO contraindication for MR: glomerular filtration rate (GFR) >60ml/dk, no claustrophobia, no prosthesis or cardiac pacemaker which is not suitable for MR no contraindication for stopping antiaggregant or antithrombotic treatment. no history of previous prostate biopsy no diagnosis of prostate cancer or other malignancies
Key exclusion criteria (4 listed)
- not approving the biopsy and MR imaging
- having prosthesis or cardiac pace maker not suitable for MR
- having contraindication for stopping antiaggregant or antithrombotic treatment.
- history of previous prostate biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mpMR guided MR-US fusion transrectal prostate biopsyAlso: Fusion biopsympMR images will be loaded to US fusion platform and registration of the will be performed. Suspicious lesions on MR which have PIRADS score 3 and above are targeted. Additional 2-4 cores biopsies will be taken them | Procedure or surgery | fusion arm |
| 12 core standard transrectal prostate biopsyAlso: STRUS-BUnder the guidance of transrectal ultrasonography, 12 core biopsies taken from apex, apex lateral, mid, mid lateral, base and base lateral of right and left prostate lobe | Procedure or surgery | Standard arm |
Primary outcome
cancer detection rate of MR-US fusion biopsies
Time frame: 15 days after biopsy
percentage of prostate cancer detected by fusion biopsies
clinically significant cancer detection rate of MR-US fusion biopsies
Time frame: 15 days after biopsy
percentage of prostate cancer which is ISUP group 2 and above detected by fusion biopsies
cancer detection rate of STRUS-B
Time frame: 15 days after biopsy
percentage of prostate cancer detected by STRUS-B
clinically significant cancer detection rate of STRUS-B
Time frame: 15 days after biopsy
percentage of prostate cancer which is ISUP group 2 and above detected by STRUS-B
cancer detection rate of combined method (fusion + STRUS-B )
Time frame: 15 days after biopsy
percentage of prostate cancer detected by combined method
clinically significant cancer detection rate of combined method (fusion + STRUS-B )
Time frame: 15 days after biopsy
percentage of prostate cancer which is ISUP group 2 and above detected by combined method
6 secondary outcomes
Visual analogue Scale score for pain
Time frame: Just after the biopsy
Comparison of the cancer detection rate of different core numbers taken from MR lesion.
Time frame: 15 days after biopsy
Neutrophil to lymphocyte ratio to predict cancer in different PRIADS lesions.
Time frame: 15 days after biopsy
Role of Systemic immune-infllamatuary index to predict the caner in PIRADS 3,4 5 lesions
Time frame: 15 days after biopsy
Tumor upgrade rate of MR US fusion biopsy in radical prostatectomy specimens
Time frame: 15 days after radical prosatetctomy
Tumor laterality in biopsy specimens and radical prostatectomy specimens
Time frame: 15 days after radical prosatetctomy
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 1 Sep 2020.
- Background: PubMed 24700068Durmus T, Baur A, Hamm B. Multiparametric magnetic resonance imaging in the detection of prostate cancer. Aktuelle Urol. 2014 Mar;45(2):119-26. doi: 10.1055/s-0034-1371875. Epub 2014 Apr 3.
- Background: PubMed 24581731Hong CW, Amalou H, Xu S, Turkbey B, Yan P, Kruecker J, Pinto PA, Choyke PL, Wood BJ. Prostate biopsy for the interventional radiologist. J Vasc Interv Radiol. 2014 May;25(5):675-84. doi: 10.1016/j.jvir.2013.12.568. Epub 2014 Feb 26.
- Background: PubMed 24579148Liao S, Gao Y, Oto A, Shen D. Representation learning: a unified deep learning framework for automatic prostate MR segmentation. Med Image Comput Comput Assist Interv. 2013;16(Pt 2):254-61. doi: 10.1007/978-3-642-40763-5_32.
- Background: PubMed 26492179Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530.
- Background: PubMed 26361169Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.
- Results publication: PubMed 23608676Kuru TH, Roethke MC, Seidenader J, Simpfendorfer T, Boxler S, Alammar K, Rieker P, Popeneciu VI, Roth W, Pahernik S, Schlemmer HP, Hohenfellner M, Hadaschik BA. Critical evaluation of magnetic resonance imaging targeted, transrectal ultrasound guided transperineal fusion biopsy for detection of prostate cancer. J Urol. 2013 Oct;190(4):1380-6. doi: 10.1016/j.juro.2013.04.043. Epub 2013 Apr 19.
- Results publication: PubMed 24666839Pokorny MR, de Rooij M, Duncan E, Schroder FH, Parkinson R, Barentsz JO, Thompson LC. Prospective study of diagnostic accuracy comparing prostate cancer detection by transrectal ultrasound-guided biopsy versus magnetic resonance (MR) imaging with subsequent MR-guided biopsy in men without previous prostate biopsies. Eur Urol. 2014 Jul;66(1):22-9. doi: 10.1016/j.eururo.2014.03.002. Epub 2014 Mar 14.
- Results publication: PubMed 25591786Junker D, Schafer G, Heidegger I, Bektic J, Ladurner M, Jaschke W, Aigner F. Multiparametric magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy of the prostate: preliminary results of a prospective single-centre study. Urol Int. 2015;94(3):313-8. doi: 10.1159/000365489. Epub 2015 Jan 9.
- Results publication: PubMed 24126797Abd-Alazeez M, Kirkham A, Ahmed HU, Arya M, Anastasiadis E, Charman SC, Freeman A, Emberton M. Performance of multiparametric MRI in men at risk of prostate cancer before the first biopsy: a paired validating cohort study using template prostate mapping biopsies as the reference standard. Prostate Cancer Prostatic Dis. 2014 Mar;17(1):40-6. doi: 10.1038/pcan.2013.43. Epub 2013 Oct 15.
- Results publication: PubMed 22982424Delongchamps NB, Peyromaure M, Schull A, Beuvon F, Bouazza N, Flam T, Zerbib M, Muradyan N, Legman P, Cornud F. Prebiopsy magnetic resonance imaging and prostate cancer detection: comparison of random and targeted biopsies. J Urol. 2013 Feb;189(2):493-9. doi: 10.1016/j.juro.2012.08.195. Epub 2012 Oct 8.
- Derived from this study: PubMed 33102391Sonmez G, Demirtas T, Tombul ST, Ozturk F, Demirtas A. What is the ideal number of biopsy cores per lesion in targeted prostate biopsy? Prostate Int. 2020 Sep;8(3):112-115. doi: 10.1016/j.prnil.2020.03.004. Epub 2020 Apr 23.
- Individual participant dataSharing planned: No
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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.
Abdullah Demritas, Assoc Prof principal investigator
Erciyes University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mpMR guided MR-US fusion transrectal prostate biopsy and 12 core standard transrectal prostate biopsy in people with Prostate Cancer, run by TC Erciyes 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 1 inclusion and 4 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 1 Sep 2020. 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?
cancer detection rate of MR-US fusion biopsies (time frame: 15 days after biopsy). The study lists 6 primary outcomes in all. 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 NCT03936296, which also lists 11 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 1 Sep 2020.