Evaluating 18F-rhPSMA-7.3 PETMRI to Predict Lymph Node Spread in High-Risk Localized Prostate Cancer Before Radical Prostatectomy

What this Trial Is About

Researchers are evaluating the use of a special imaging scan called 18F-rhPSMA-7.3 PETMRI to detect the risk of prostate cancer spreading to lymph nodes in men with localized high-risk prostate cancer who are scheduled for radical prostatectomy. This method aims to improve the accuracy of identifying patients who might benefit from pelvic lymph node dissection. The study focuses on newly diagnosed patients who have not received prior treatments and are planned for surgery. Participants receive an intravenous injection of the 18F-rhPSMA-7.3 tracer and undergo PETMRI imaging up to 30 days before their standard robotic radical prostatectomy with bilateral pelvic lymph node dissection. Additional imaging such as CT, MRI, or bone scans and tissue sample collection are performed during screening. After surgery, patients are followed up at 6 weeks, 3 months, 9 months, and 12 months to monitor their condition. Throughout the study, researchers will assess diagnostic measures like sensitivity, specificity, and predictive values of the imaging to detect lymph node metastasis. They will also track prostate-specific antigen PSA levels and rates of biochemical recurrence up to 12 months after surgery. Various clinical evaluations, including digital rectal exams and Gleason scores, are conducted. The study duration for each participant includes the screening, imaging, surgery, and one-year follow-up to gather comprehensive data on the imagings accuracy and patient outcomes.

Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer