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

ConditionProstatic Neoplasm of Uncertain Behavior

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-99

SponsorSalzburger Landeskliniken

About this trial

\*\*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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Patients with histopathologic proven prostate cancer

PSA > 20 ng/ml

Finding in digital rectal examination >= cT2c

Untreated bacterial infection of the prostate

Trial design

Design model

Parallel

Treatments tested in this trial

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
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

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Group UExperimental treatment 1 intervention

Group B: Group SActive comparator 1 intervention

Trial outcomes

Primary outcomes

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".

Time frame

2 Weeks

Secondary outcomes

Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy

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".

Time frame

2 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salzburger Landeskliniken

Lead sponsor

Source ClinicalTrials.gov

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