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

NCT06579911 | Recruiting

• 1 other identifier: Biopsy29
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

\*\*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:\*\*

• 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.

Conditions

Prostatic Neoplasm of Uncertain Behavior

Keywords

Prostate cancer; prostate biopsy; high frequency ultrasound; fusion biopsy; multiparametric mri of prostate; pirads; primus

Outcome Measures

Primary Outcomes (1)

• Detection of Clinically Significant Prostate Cancer via Prostate Biopsy

  This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no".

  2 Weeks

Secondary Outcomes (1)

• Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy

  2 Weeks

Study Arms (2)

Group U

EXPERIMENTAL

Use of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection

Device: High-frequency micro-ultrasound target biopsy

Group S

ACTIVE COMPARATOR

Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection

Device: conventional Multiparametric MRT target biopsy

Interventions

High-frequency micro-ultrasound target biopsy DEVICE

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

Group U

conventional Multiparametric MRT target biopsy DEVICE

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

Group S

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

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

Sponsors & Collaborators

• Salzburger Landeskliniken: lead

Study Sites (1)

Uniklinikum Salzburg, Department for Urology and Andrology

Salzburg, Salzburg, 5020, Austria

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.

  PMID: 30470502 BACKGROUND

• 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 BACKGROUND

• 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.0000000000001083. Epub 2020 Apr 21.

  PMID: 32314932 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cornud F, Lefevre A, Flam T, Dumonceau O, Galiano M, Soyer P, Camparo P, Barral M. MRI-directed high-frequency (29MhZ) TRUS-guided biopsies: initial results of a single-center study. Eur Radiol. 2020 Sep;30(9):4838-4846. doi: 10.1007/s00330-020-06882-x. Epub 2020 Apr 29.

  PMID: 32350662 BACKGROUND

• Wiemer L, Hollenbach M, Heckmann R, Kittner B, Plage H, Reimann M, Asbach P, Friedersdorff F, Schlomm T, Hofbauer S, Cash H. Evolution of Targeted Prostate Biopsy by Adding Micro-Ultrasound to the Magnetic Resonance Imaging Pathway. Eur Urol Focus. 2021 Nov;7(6):1292-1299. doi: 10.1016/j.euf.2020.06.022. Epub 2020 Jul 9.

  PMID: 32654967 BACKGROUND

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 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: Biopsy29

Model Details: Participants are randomly divided into two groups. One group (the experimental group) receives the combination of high-frequency micro-ultrasound, multiparametric MRI-targeted biopsy, and systematic biopsy. The other group (the control group) receives the current standard care, which includes only multiparametric MRI-targeted biopsy and systematic biopsy. This setup allows direct comparison of the detection rates of clinically significant prostate cancer between the new combination of interventions and the standard approach.

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)