Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and MR-guided Fusion Transrectal Prostate Biopsy

NCT03936296 | Completed

• 1 other identifier: TSG-2016-5200
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

multiparametric prostate magnetic resonance imaging; MR-US fusion; MR guided prostate biopsy; prostate cancer

Outcome Measures

Primary Outcomes (6)

• cancer detection rate of MR-US fusion biopsies

  percentage of prostate cancer detected by fusion biopsies

  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

  15 days after biopsy

• cancer detection rate of STRUS-B

  percentage of prostate cancer detected by STRUS-B

  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

  15 days after biopsy

• cancer detection rate of combined method (fusion + STRUS-B )

  percentage of prostate cancer detected by combined method

  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

  15 days after biopsy

Secondary Outcomes (6)

• Visual analogue Scale score for pain

  Just after the biopsy

• Comparison of the cancer detection rate of different core numbers taken from MR lesion.

  15 days after biopsy

• Neutrophil to lymphocyte ratio to predict cancer in different PRIADS lesions.

  15 days after biopsy

• Role of Systemic immune-infllamatuary index to predict the caner in PIRADS 3,4 5 lesions

  15 days after biopsy

• Tumor upgrade rate of MR US fusion biopsy in radical prostatectomy specimens

  15 days after radical prosatetctomy

Study Arms (2)

fusion arm

ACTIVE COMPARATOR

Patients in this arm will be undertaken standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy

Procedure: mpMR guided MR-US fusion transrectal prostate biopsy

Standard arm

OTHER

Patients in this arm will be undertaken only standard transrectal prostate biopsy

Procedure: 12 core standard transrectal prostate biopsy

Interventions

mpMR guided MR-US fusion transrectal prostate biopsy PROCEDURE

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

Also known as: Fusion biopsy

fusion arm

12 core standard transrectal prostate biopsy PROCEDURE

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

Also known as: STRUS-B

Standard arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 24700068 BACKGROUND

• Hong 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.

  PMID: 24581731 BACKGROUND

• Liao 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.

  PMID: 24579148 BACKGROUND

• Epstein 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.

  PMID: 26492179 BACKGROUND

• Barentsz 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.

  PMID: 26361169 BACKGROUND

• Kuru 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.

  PMID: 23608676 RESULT

• Pokorny 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.

  PMID: 24666839 RESULT

• Junker 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.

  PMID: 25591786 RESULT

• Abd-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.

  PMID: 24126797 RESULT

• Delongchamps 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.

  PMID: 22982424 RESULT

• Sonmez 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.

  PMID: 33102391 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Abdullah Demritas, Assoc Prof

  Erciyes University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, Assoc Prof

Model Details: To perform standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy in the 2 randomized patient group

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 3, 2019
• Study Start: December 6, 2017
• Primary Completion: June 30, 2020
• Study Completion: August 28, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)