RecruitingNot ApplicableNCT06389786

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


Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Jun 11, 2024

Study Type

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

Sex: MALEMin Age: 30 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special type of imaging scan — called a PSMA PET/MRI — can accurately predict whether prostate cancer has spread to nearby lymph nodes before surgery. Doctors want to know if this scan can help them plan surgery better. **You may be eligible if...** - You are a man between 30 and 85 years old - You have been diagnosed with high-risk prostate cancer that has not been treated yet - You are scheduled for surgery to remove your prostate (radical prostatectomy) along with removal of nearby lymph nodes - You have no more than 3 lymph nodes that appear positive on standard imaging **You may NOT be eligible if...** - You have had radiation therapy to your pelvis before - You have received hormone therapy (such as Lupron) in the past 12 weeks - You have received chemotherapy or immune-suppressing drugs recently - You have a BMI over 40 (severe obesity) - You have had a prior hernia repair with mesh in your groin area - You cannot lie still for about 75 minutes during the scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Undergo robotic radical prostatectomy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI or PET/MRI

PROCEDUREPositron Emission Tomography

Undergo PET/MRI


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06389786


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