A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 to Treat Prostate Cancer

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Full Title

A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA-617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

Purpose

In this study, researchers want to see if giving the drug 177Lu-PSMA-617 followed by stereotactic body radiation therapy (SBRT) is safe for men with prostate cancer that is responsive to hormonal therapy (“hormone-sensitive prostate cancer”) and has spread to one to three sites. 177Lu-PSMA-617 targets prostate cancer cells and delivers radiation directly into the tumor to destroy cancer cells.

Studies have shown that men who are treated with SBRT alone are at risk of having their cancer come back after treatment or spread to other parts of the body. Doctors think that combining SBRT with 177Lu-PSMA-617 may be a safe treatment that could reduce the risk that the cancer will come back or spread. It is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have prostate cancer that was treated with surgery and/or radiation therapy, with initial treatment completed at least 2 years before entering the study.
  • Their disease must have spread to only one to three sites in the body.
  • Patients’ cancers must be responsive to hormonal therapy, but they may not be currently taking hormonal therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for men age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Michael Zelefsky at 212-639-6802.

Protocol

21-158

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05079698