TheranosticTrials.org

Clinical Trial · NCT06105918

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

Overview

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.

Sponsor

Emory University

Phase

Phase 1

Contacts

David M Schuster, MD, FACR (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06105918

Drug / Compound

rhPSMA-7.3

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

PSMA-10.1

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Age over 18
  • Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed, pelvic lymph node uptake, or both)
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
  • * Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate specific antigen (PSA)

Exclusion

  • Risk factors for Lu-rhPSMA radioligand therapy (Baseline \>= grade 2 myelosuppression, renal insufficiency \[glomerular filtration rate (GFR) \< 60 mL/min\], or xerostomia)
  • Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or who are at high risk of urinary retention
  • Unacceptable medical or radiation safety risk
  • Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if obtained)
  • * Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy or prior RLT)