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

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.

Conditions

• Biochemically Recurrent Prostate Carcinoma
• Prostate Adenocarcinoma

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• David M Schuster, MD, FACR · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-29

Primary Completion

2028-04-01

Completion

2029-04-01

FDA Drug

Yes

Countries

• United States

Study Locations