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NCT Number: NCT06579911

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

**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.

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Key information

Conditions

Prostatic Neoplasm of Uncertain Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Uniklinikum Salzburg, Department for Urology and Andrology

Salzburg, State of Salzburg, 5020, Austria

Location status: Recruiting

Location contact

Lukas Lusuardi, Univ.Prof.Dr.

CONTACT

[email protected]

0043 57255 27402

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-frequency micro-ultrasound target biopsy

Device
  • 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.
  • Multiparametric MRI target biopsy (PI-RADS >= 3) of the prostate (transrectal ultrasound, 29 Hz, ExactVu). Maximum of four cores per lesion.
  • Systematic biopsy (twelve cores) of the prostate

conventional Multiparametric MRT target biopsy

Device
  • Multiparametric MRT target biopsy (PI-RADS >= 3) of the prostate (conventional transrectal ultrasound, 8-10 Hz). Maximum of four cores per lesion.
  • Systematic biopsy (twelve cores) of the prostate

Primary outcomes

  1. Detection of Clinically Significant Prostate Cancer via Prostate Biopsy

    Time frame: 2 Weeks

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

Secondary outcomes

  1. Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy

    Time frame: 2 Weeks

    This measure evaluates whether participants have clinically insignificant prostate cancer (Gleason Score Sum = ISUP 1) based on biopsy results, also recorded as "yes" or "no".

Sponsors and collaborators

Lead sponsor

Salzburger Landeskliniken

Other

Registry information

Official study 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

Acronym: Biopsy29

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 30, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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