Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
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
50 participants
Jun 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 within 6 months of surgery
- Patient agrees to comply with the investigator instructions
- Patient agrees to comply with the follow-up surveillance schedule
- Have ability to provide full written consent
Exclusion Criteria12
- 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
- Previous history of pelvic radiation
- Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2
- History of prior laparoscopic inguinal hernia repair with mesh
- Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging
- Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
- Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
- Received administration of an investigational drug within 30 days prior to study registration, and/or has planned administration of another investigational product or procedure during participation in this study
Interventions
Undergo bilateral pelvic lymph node dissection
Undergo tissue sample collection
Undergo bone scan
Undergo CT
Ancillary studies
Given IV
Undergo robotic radical prostatectomy
Undergo MRI or PET/MRI
Undergo PET/MRI
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06389786