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.
Male subjects ≥ 30 and ≤ 85 years old
Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)
Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling
Planned elective radical prostatectomy with extended pelvic lymph node dissection
High-risk cancer planned for neoadjuvant therapy
Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration
Clinical oligometastatic disease with > 3 nodes positive preoperative standard of care imaging of prostate region
Single group
Bilateral Pelvic Lymph Node Dissection
Procedure/SurgeryUndergo bilateral pelvic lymph node dissection
Biospecimen Collection
Procedure/SurgeryUndergo tissue sample collection
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo CT
Electronic Health Record Review
Other interventionAncillary studies
Flotufolastat F-18 Gallium
Other interventionGiven IV
Laparoscopic Radical Prostatectomy with Robotics
Procedure/SurgeryUndergo robotic radical prostatectomy
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI or PET/MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET/MRI
Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis
Defined as the presence of lymph node positivity determined on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI. Continuous variables will be summarized as mean (standard deviation) or median (range) while categorical variables will be reported as frequency (percentage).
Specificity
Defined as absence of lymph node metastasis on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI.
Positive predictive value//negative predictive value (PPV/NPV)
Defined as findings on 18F-rhPSMA-7.3 prostate specific membrane antigen (PSMA) PET/MRI compared to the presence or absence of lymph node metastasis on final pathologic analysis. Proportion of correct results will be compared between rhPSMA-7.3(18F) PET/MRI and the standard care.
Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20
Will investigate the impact of PSA as a clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3.
Gleason score
Will investigate the impact of Gleason score as a clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3. Gleason score is a grading system for prostate cancer ranging from 6 (low-grade cancer) to 10 (high-grade cancer).
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