Evaluating the role of 18F-PSMA PET imaging in prostate cancer
Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer
IRCCS San Raffaele · NCT06167629
This study is testing how well 18F-PSMA PET imaging can help doctors understand and predict the progression of prostate cancer in patients at different stages of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06167629 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic and prognostic capabilities of 18F-PSMA PET imaging in patients with prostate cancer at various stages. It will analyze both PET images and associated CT or MR images to enhance anatomical localization and understanding of the disease. The study will include both retrospective and prospective data collection to ensure a robust statistical analysis, focusing on the predictive value of imaging features related to disease progression and mortality.
Who should consider this trial
Good fit: Ideal candidates include adult male patients with a histopathological diagnosis of prostate cancer who are undergoing staging or restaging and have a clinical indication for 18F-PSMA PET examination.
Not a fit: Patients with medical conditions that prevent the acquisition of PET images or those with allergic reactions to iodinated contrast medium may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of prostate cancer diagnosis and prognosis, leading to better patient management.
How similar studies have performed: While the methodology of using radiomic features in PET imaging is promising, it is relatively novel and has not been extensively standardized in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult male patients; * patients with histopathological diagnosis of prostate cancer undergoing staging or restaging; * patients with clinical indication for PET examination with 18 F-PSMA; Exclusion Criteria: * medical conditions that do not allow the acquisition of PET images; * allergic reactions to iodinated contrast medium or creatinine levels \>2mg/dL.
Where this trial is running
Milan
- IRC — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Arturo Chiti
- Email: chiti.arturo@hsr.it
- Phone: 0226432716
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: Prostate Cancer