Combining advanced imaging techniques to improve prostate cancer detection
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
NA · Salzburger Landeskliniken · NCT06579911
This study is testing if using advanced imaging techniques together can help find more serious prostate cancers in men better than standard biopsy methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Salzburger Landeskliniken (other) |
| Locations | 1 site (Salzburg, State of Salzburg) |
| Trial ID | NCT06579911 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether the combination of high-frequency micro-ultrasound and multiparametric MRI-targeted biopsy can enhance the detection of clinically significant prostate cancer compared to standard biopsy methods. Participants will undergo a series of procedures including high-frequency micro-ultrasound examination, multiparametric MRI-targeted biopsy, and systematic biopsy. The study will assess if this new approach can identify more significant cancers without increasing the detection of less serious forms. The findings could lead to improved diagnostic accuracy for men suspected of having prostate cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are men with suspected clinically significant prostate cancer indicated by elevated PSA levels or suspicious digital rectal examinations.
Not a fit: Patients who already have a confirmed diagnosis of prostate cancer or those with very high PSA levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of clinically significant prostate cancers, potentially improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving cancer detection rates, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Salzburg, State of Salzburg
- Uniklinikum Salzburg, Department for Urology and Andrology — Salzburg, State of Salzburg, Austria (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostatic Neoplasm of Uncertain Behavior, Prostate cancer, prostate biopsy, high frequency ultrasound, fusion biopsy, multiparametric mri of prostate, pirads, primus