TheranosticTrials.org

Clinical Trial · NCT05079698

A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer

Overview

The researchers are doing this study to find out whether giving 177Lu-PSMA-617 followed by a type of radiation therapy called SBRT (stereotactic body radiation therapy) is a safe treatment for your cancer. The study agent has been shown to target tumor cells, and the researchers think that adding 177Lu-PSMA-617 to SBRT may prevent or delay the cancer from continuing to spread.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

Phase 1

Contacts

Brandon Imber, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05079698

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

DCFPyL

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

PSMA-617

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

Eligibility

Inclusion

  • The patient's primary tumor must have been previously treated with surgery and/or definitive radiation. Prior salvage treatments (radiation or surgery) to the prostate bed or pelvis is allowed.
  • Platelets ≥ 100 K/mcL
  • Patient must have 1-5 oligometastatic tumors or lesions of the bone or soft tissue that are detectable on a PSMA PET scan.
  • Baseline testosterone below the normal range for patients who have not had hormone therapy within 12 months of study entry is acceptable
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or the equivalent KPS conversion value of ≥ 60 .
  • Patient must have a prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL

Exclusion

  • Patients with prior radiotherapy to \> 25% of the skeleton or prior exposure to prior 223Radium, 89Strontium or 153Samarium containing compounds
  • Patients with a PSMA scan within 2 months of enrollment that do not demonstrate metastatic lesions or demonstrate more than 5 discrete metastatic lesions
  • Patients with documented castration resistant prostate cancer (CRPC)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration.