RecruitingNot Applicable

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

Austria400 participantsStarted 2023-11-01

Plain-language 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:\*\* 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.

Who can participate

Age range

18 Years – 99 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines high-frequency micro-ultrasound with multiparametric MRI to guide the biopsy — how does using both imaging methods together compare to what would normally be done for my situation, and could it change what areas of my prostate get sampled?
2Since my diagnosis is listed as 'prostatic neoplasm of uncertain behavior,' would joining this trial mean my biopsy is handled differently than the standard approach, and could that affect how quickly or accurately we find out whether I have clinically significant cancer?
3This trial is listed as phase 'NA,' which suggests it's more of a diagnostic study than a drug trial — does that mean the main risks are still the usual biopsy risks, or are there any added risks from using the micro-ultrasound technology during the procedure?
4If this trial's combined imaging approach detects something that a standard MRI-guided biopsy might miss, or vice versa, how would that finding actually change my treatment plan going forward?
5Before I consider enrolling in this study, would it make sense to first complete a standard multiparametric MRI-guided biopsy on its own, or is there a reason my doctor thinks participating in this comparison trial would be a better first step for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detection of Clinically Significant Prostate Cancer via Prostate Biopsy

Timeframe: 2 Weeks

Trial details

NCT IDNCT06579911

SponsorSalzburger Landeskliniken

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

View on ClinicalTrials.gov More Prostatic Neoplasm of Uncertain Behavior trials