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ACTIVE NOT RECRUITING
NCT06105918
PHASE1

Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer

Sponsor: Emory University

View on ClinicalTrials.gov

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

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo rhPSMA-7.3 PET/CT and SPECT-CT

RADIATION

External Beam Radiation Therapy

Undergo EBRT

OTHER

Flotufolastat F-18

Given IV

DRUG

Lutetium Lu 177 PSMA-10.1

Given IV

PROCEDURE

Positron Emission Tomography

Undergo rhPSMA-7.3 PET/CT

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT-CT scan

Locations (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States