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Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer
Sponsor: Emory University
Summary
This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \[177Lu-rhPSMA-10.1\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.
Official title: Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy With PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2023-11-29
Completion Date
2029-04-01
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo rhPSMA-7.3 PET/CT and SPECT-CT
External Beam Radiation Therapy
Undergo EBRT
Flotufolastat F-18
Given IV
Lutetium Lu 177 PSMA-10.1
Given IV
Positron Emission Tomography
Undergo rhPSMA-7.3 PET/CT
Single Photon Emission Computed Tomography
Undergo SPECT-CT scan
Locations (1)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States