Using advanced imaging to diagnose significant prostate cancer
Official title: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
Run by IRCCS San Raffaele · NCT06305390 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 167 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Status | Recruiting |
| Started | December 4, 2023 |
| Main results expected | March 24, 2026 |
| Study ends | April 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT06305390 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using advanced imaging techniques for prostate cancer diagnosis, suggesting potential success for this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effective Communication in VBAC Counseling
This study tests how clearly doctors and midwives explain VBAC options during prenatal visits and whether patients feel understood.
-
CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults
This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.
-
Photon-counting CT versus traditional CT for suspected coronary artery disease
This trial tests whether photon-counting CT can better diagnose obstructive CAD in people who need a coronary CTA than the standard energy-integrating detector CT.
-
Intensive 4-week postoperative multimodal rehab after proximal pancreatic surgery
This study tests whether a 4-week multimodal rehabilitation program can help adults who have severe complications after proximal pancreatic surgery recover better.
-
Engineered HMGB1 protein as a companion therapy for LAMA2-related muscular dystrophy
This study tests how existing patient samples from people with LAMA2-related muscular dystrophy can be used to explore a potential companion therapy using an engineered HMGB1 protein.
-
OCT in Neurological Practice: Use of Retinal Layers to Help Diagnose and Follow Neurological Diseases
This study tests whether optical coherence tomography (OCT) of the retina can help in diagnosing and tracking multiple sclerosis, Alzheimer's, Parkinson's, migraines, and other headaches compared with healthy people.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.