nctId: NCT06389786 id: MC230504 id: NCI-2024-03306 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009377 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230504 type: OTHER domain: Mayo Clinic briefTitle: Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy. conditions: Localized Prostate Carcinoma conditions: Oligometastatic Prostate Carcinoma conditions: Stage I Prostate Cancer AJCC v8 conditions: Stage II Prostate Cancer AJCC v8 conditions: Stage III Prostate Cancer AJCC v8 conditions: Stage IVA Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: Bilateral Pelvic Lymph Node Dissection name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Electronic Health Record Review name: Flotufolastat F-18 Gallium name: Laparoscopic Radical Prostatectomy with Robotics name: Magnetic Resonance Imaging name: Positron Emission Tomography measure: Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis measure: Specificity measure: Positive/negative predictive value measure: Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20 measure: Gleason score measure: Digital rectal examination measure: Number of patients where management has changed measure: Rates of biochemical recurrent disease (BCR) sex: MALE minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Ram A. Pathak, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False