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Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
Sponsor: Mayo Clinic
Summary
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.
Official title: MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET/CT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis
Key Details
Gender
MALE
Age Range
30 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-06-11
Completion Date
2027-05-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Bilateral Pelvic Lymph Node Dissection
Undergo bilateral pelvic lymph node dissection
Biospecimen Collection
Undergo tissue sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Flotufolastat F-18 Gallium
Given IV
Laparoscopic Radical Prostatectomy with Robotics
Undergo robotic radical prostatectomy
Magnetic Resonance Imaging
Undergo MRI or PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, United States