protocolSection identificationModule nctId: NCT06389786, orgStudyIdInfo id: MC230504, secondaryIdInfos id: NCI-2024-03306, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-009377, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule 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., conditionsModule 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, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral Pelvic Lymph Node Dissection, interventions name: Biospecimen Collection, interventions name: Bone Scan, interventions name: Computed Tomography, interventions name: Electronic Health Record Review, interventions name: Flotufolastat F-18 Gallium, interventions name: Laparoscopic Radical Prostatectomy with Robotics, interventions name: Magnetic Resonance Imaging, interventions name: Positron Emission Tomography, outcomesModule primaryOutcomes 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, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Positive/negative predictive value, secondaryOutcomes measure: Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20, secondaryOutcomes measure: Gleason score, secondaryOutcomes measure: Digital rectal examination, secondaryOutcomes measure: Number of patients where management has changed, secondaryOutcomes measure: Rates of biochemical recurrent disease (BCR), eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Ram A. Pathak, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False