Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer
NCT ID: NCT06579911
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-11-01
2026-01-01
Brief Summary
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\*\*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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group U
Use of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection
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
Group S
Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* PSA \> 20 ng/ml
* Finding in digital rectal examination \>= cT2c
* Untreated bacterial infection of the prostate
* Untreated coagulopathy
18 Years
99 Years
MALE
Yes
Sponsors
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Salzburger Landeskliniken
OTHER
Responsible Party
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Maximilian Pallauf
Biopsy29
Locations
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Uniklinikum Salzburg, Department for Urology and Andrology
Salzburg, Salzburg, Austria
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Biopsy29
Identifier Type: -
Identifier Source: org_study_id
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