Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer (Biopsy29)

Salzburger Landeskliniken

Status: Enrolling

Conditions: Prostatic Neoplasm of Uncertain Behavior

Treatments: Device: conventional Multiparametric MRT target biopsy; Device: High-frequency micro-ultrasound target biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06579911

Biopsy29

Details and patient eligibility

About

**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.

Full 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).

Enrollment: 400 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Group U

Experimental group

Description:

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

Treatment:

Device: High-frequency micro-ultrasound target biopsy

Group S

Active Comparator group

Description:

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

Treatment:

Device: conventional Multiparametric MRT target biopsy