Using micro-ultrasound to diagnose prostate cancer
Micro-ultrasound or MRI-targeted Biopsy for Prostate Cancer Diagnosis
This study is testing if a new type of ultrasound can find prostate cancer just as well or better than an MRI in men who might have the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT04832997 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of micro-ultrasound compared to multiparametric MRI in diagnosing clinically significant prostate cancer (csPCa). Patients suspected of having prostate cancer will undergo both imaging techniques in separate visits, and the results will guide the type of prostate biopsies performed. The study aims to determine if micro-ultrasound can provide equal or superior sensitivity for detecting csPCa compared to MRI. Participants will be categorized based on their imaging results to receive appropriate biopsy procedures.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with a clinical suspicion of prostate cancer who are advised to undergo a biopsy.
Not a fit: Patients with a prior diagnosis or treatment for prostate cancer, or those with contraindications to MRI or biopsy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of prostate cancer diagnoses, leading to better-targeted treatments.
How similar studies have performed: Other studies have shown promising results using similar imaging techniques for prostate cancer diagnosis, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy * Serum PSA ≤ 20ng/ml * Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) * Fit to undergo all procedures listed in protocol * Able to provide written informed consent Exclusion Criteria: * Prior treatment for prostate cancer * Prior diagnosis of prostate cancer * Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min) * Contraindication to prostate biopsy * Men in whom artifact would reduce the quality of the MRI * Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work * Unfit to undergo any procedures listed in protocol
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Armando Stabile
- Email: stabile.armando@hsr.it
- Phone: +39 0226435660
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.