Using PET/MRI to stage prostate cancer patients
Phase II Monocentric Study to Evaluate a Novel Approach for Staging Prostate Cancer Patients by Using a Fully Integrated Hybrid PET/MRI
This study is testing a new imaging method using PET/MRI scans to see if it can better stage prostate cancer in patients before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06484361 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate a new method for staging prostate cancer patients using a fully integrated PET/MRI system with 68Ga-PSMA and 68Ga-RM2. The study will involve 50 patients with biopsy-proven prostate cancer who will undergo two separate PET/MRI scans within a month. Following imaging, participants will have prostatectomy and pelvic lymphadenectomy, allowing for detailed analysis of the tumor and surrounding tissues. The study will also involve correlating imaging findings with histopathological results to enhance staging accuracy.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with high-grade prostate cancer who are scheduled for prostatectomy.
Not a fit: Patients with evidence of metastatic disease or those unable to undergo MRI due to medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging of prostate cancer, potentially improving treatment outcomes.
How similar studies have performed: While the use of PET/MRI in cancer staging is gaining traction, this specific combination of imaging agents and methodology is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years-old * Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy. * Willing to provide a signed informed consent Exclusion Criteria: * Age \< 18 years-old * Inability to complete the needed imaging examinations (i.e. severe claustrophobia) * Any additional medical condition that may significantly interfere with study compliance * All the contraindications for MRI study (i.e. pacemaker) * Evidence of metastatic disease on conventional imaging contraindicating the surgical procedure
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Picchio, MD
- Email: picchio.maria@hsr.it
- Phone: +39 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.