Using advanced imaging to diagnose significant prostate cancer
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
This study is testing a new imaging method that combines PET and MRI scans to see if it can better diagnose significant prostate cancer and reduce the need for unnecessary biopsies in patients at low risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 167 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06305390 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effectiveness of a fully hybrid PET/MRI approach using 18F-PSMA and multiparametric MRI to diagnose clinically significant prostate cancer. The study aims to determine if this combined imaging technique can reduce false negative results and minimize unnecessary biopsies in patients with low-risk prostate cancer. By integrating these imaging modalities, the researchers hope to enhance diagnostic accuracy before proceeding to biopsy.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have a clinical suspicion of prostate cancer and are candidates for a prostate biopsy.
Not a fit: Patients with a prior diagnosis of prostate cancer or those who have contraindications to MRI or prostate biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of prostate cancer and reduce the number of unnecessary biopsies for patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for prostate cancer diagnosis, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy 2. Feasibility to undergo all procedures listed in protocol 3. Ability to provide written informed consent Exclusion Criteria: 1. Prior diagnosis of prostate cancer 2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min) 3. Contraindication to prostate biopsy
Where this trial is running
Milan, Milano
- U.O. of Nuclear Medicine, ,Ospedale San Raffaele — Milan, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Picchio, MD
- Email: Picchio.maria@hsr.it
- Phone: 02-26436117
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.