Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer

Official title

Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does it Increase the Detection Rate of Clinically Significant Prostate Cancer? A Prospective, Interventional, Single Centre, Randomized Controlled Trial

Overview

\*\*Study Goal:\*\* The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer. \*\*Main Questions the Study Aims to Answer:\*\* 1. Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method? 2. Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects? \*\*Participation in the Study:\*\* Participants in this study will undergo the following procedures: * A high-frequency micro-ultrasound examination of the prostate. * A multiparametric MRI-targeted biopsy of the prostate. * A systematic biopsy of the prostate. \*\*Comparison Group:\*\* Researchers will compare the new combination method with the current standard method to see if the new approach is more effective. \*\*Participants will:\*\* * Undergo several exams and biopsies depending on the results of previous tests. * Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health. * Record their experiences and any symptoms in a diary.

Detailed description

The primary objective of this study is (i) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy detects more clinically significant prostate cancer (\>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).

The secondary objective of this study is (ii) to demonstrate that the combination of high frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy does not detect more clinically insignificant prostate cancer (ISUP 1) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).

The third objective of this study is (iii) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer (\>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy (current standard of care).

The fourth objective of this study is (iv) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer (ISUP 1) than the combination of multiparametric MRI target biopsy and systematic biopsy (current standard of care).

Interventions

• Device High-frequency micro-ultrasound target biopsy
  1. High-frequency micro-ultrasound (transrectal ultrasound, 29 Hz, ExactVu) of the prostate. If suspicious lesions (PRIMUS \>= 3) other than those already detected in multiparametric MRI are found, target biopsy will be performed. Maximum of four cores per lesion. 2. Multiparametric MRI target biopsy (PI-RADS \>= 3) of the prostate (transrectal ultrasound, 29 Hz, ExactVu). Maximum of four cores per lesion. 3. Systematic biopsy (twelve cores) of the prostate
• Device conventional Multiparametric MRT target biopsy
  1. Multiparametric MRT target biopsy (PI-RADS \>= 3) of the prostate (conventional transrectal ultrasound, 8-10 Hz). Maximum of four cores per lesion. 2. Systematic biopsy (twelve cores) of the prostate

Primary outcome measures

• Detection of Clinically Significant Prostate Cancer via Prostate Biopsy [Time frame: 2 Weeks]

Secondary outcome measures (1)

• Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy [Time frame: 2 Weeks]

Eligibility criteria

Inclusion criteria

\- Men with suspected clinically significant prostate cancer, identified by the rise in PSA level, suspicious digital rectal examination or both and pathologic multiparametric MRI of the prostate (>= PI-RADS III)

Exclusion criteria

• Patients with histopathologic proven prostate cancer
• PSA > 20 ng/ml
• Finding in digital rectal examination >= cT2c
• Untreated bacterial infection of the prostate
• Untreated coagulopathy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Austria · 1 center

• Uniklinikum Salzburg, Department for Urology and Andrology — Salzburg

Publications

• Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E, Malvezzi M. European cancer mortality predictions for the year 2020 with a focus on prostate cancer. Ann Oncol. 2020 May;31(5):650-658. doi: 10.1016/j.annonc.2020.02.009. Epub 2020 Apr 19. PMID 32321669
• Kim JK, Jang YJ, Cho G. Multidisciplinary functional MR imaging for prostate cancer. Korean J Radiol. 2009 Nov-Dec;10(6):535-51. doi: 10.3348/kjr.2009.10.6.535. PMID 19885309
• Kasivisvanathan V, Stabile A, Neves JB, Giganti F, Valerio M, Shanmugabavan Y, Clement KD, Sarkar D, Philippou Y, Thurtle D, Deeks J, Emberton M, Takwoingi Y, Moore CM. Magnetic Resonance Imaging-targeted Biopsy Versus Systematic Biopsy in the Detection of Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2019 Sep;76(3):284-303. doi: 10.1016/j.eururo.2019.04.043. Epub 2019 May 24. PMID 31130434
• Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, pa PMID 30470502
• Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12. PMID 26791931
• Rodriguez Socarras ME, Gomez Rivas J, Cuadros Rivera V, Reinoso Elbers J, Llanes Gonzalez L, Michel Mercado I, Fernandez Del Alamo J, Juarez Del Dago P, Sancha FG. Prostate Mapping for Cancer Diagnosis: The Madrid Protocol. Transperineal Prostate Biopsies Using Multiparametric Magnetic Resonance Imaging Fusion and Micro-Ultrasound Guided Biopsies. J Urol. 2020 Oct;204(4):726-733. doi: 10.1097/JU.0 PMID 32314932
• Abouassaly R, Klein EA, El-Shefai A, Stephenson A. Impact of using 29 MHz high-resolution micro-ultrasound in real-time targeting of transrectal prostate biopsies: initial experience. World J Urol. 2020 May;38(5):1201-1206. doi: 10.1007/s00345-019-02863-y. Epub 2019 Jul 15. PMID 31309290
• Laurence Klotz CM. Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Eur Urol Focus. 2020 Mar 15;6(2):419-423. doi: 10.1016/j.euf.2019.11.006. Epub 2019 Nov 24. PMID 31771935

Identifiers

NCT: NCT06579911 · Biopsy29

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗