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
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.
Description
PRIMARY OBJECTIVE: I. To investigate the diagnostic ability of flotufolastat F-18 gallium (18F-rhPSMA-7.3) PSMA PET/MRI prior to radical prostatectomy in newly diagnosed, high-risk prostate cancer patients. SECONDARY OBJECTIVES: I. Calculating the specificity, positive-predictive value, and negative-predictive value for the detection of lymph node positivity. II. Investigating the rates of biochemical recurrence (BCR) as measured by post-operative prostate specific antigen (PSA) (PSA \> 0.20) at pre-defined timepoints in patients. OUTLINE: Patients receive 18F-rhPSMA-7.3 intravenously (I…
Eligibility
- Age range
- 30–85 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region…
Interventions
- ProcedureBilateral Pelvic Lymph Node Dissection
Undergo bilateral pelvic lymph node dissection
- ProcedureBiospecimen Collection
Undergo tissue sample collection
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo CT
- OtherElectronic Health Record Review
Ancillary studies
- OtherFlotufolastat F-18 Gallium
Given IV
- ProcedureLaparoscopic Radical Prostatectomy with Robotics
Location
- Mayo Clinic in FloridaJacksonville, Florida