Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer
This study evaluates a new imaging technique using a radioactive tracer (68Ga-PSMA-11) combined with PET/MR or PET/CT scans to better detect prostate cancer. The imaging will be tested in men with newly diagnosed high-risk or intermediate prostate cancer before treatment, and in men who have had a rise in PSA levels after previous prostate cancer treatment.
Key Objective:This trial tests whether this advanced imaging approach can more accurately detect prostate cancer and help doctors plan personalized, more effective treatment for individual patients.
Who to Consider:Men with intermediate or high-risk prostate cancer before treatment, or men with rising PSA levels after previous prostate cancer treatment, should consider enrolling.
Trial Parameters
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Brief Summary
The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment
Eligibility Criteria
Inclusion Criteria: Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned * Prostate adenocarcinoma confirmed by biopsy and histopathological examination * Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score\> 7 or cT2c or PSA\> 20 ng / ml) risk according to ISUP * Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance\> 60 mL / min * Age ≥18 years * Signing informed consent to participate in the study * Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molec