A Phase III Study Comparing 177Lu-PSMA-617 plus Standard of Care versus Standard of Care Alone to Treat Metastatic Hormone-Sensitive Prostate Cancer

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Full Title

PSMAddition: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination with Standard of Care, Versus Standard of Care Alone, in Adult Male Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (WIRB)

Purpose

Treatment with hormonal therapy (specifically, androgen deprivation therapy and androgen receptor targeted therapy) is considered the standard of care for people newly diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) or who developed metastatic disease after previous treatment for early-stage prostate cancer. In this study, researchers want to see if adding the drug 177Lu-PSMA-617 to standard therapy is more effective than the standard treatment alone in people with mHSPC.

177Lu-PSMA-617 targets prostate cancer cells and delivers radiation directly into the tumor to destroy cancer cells. It is given intravenously (by vein). The hormonal therapy is taken orally (by mouth).

Eligibility

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

  • Participants must have mHSPC that is positive for the PSMA protein.
  • Prior hormonal therapy and up to 45 days of androgen receptor targeted therapy are allowed, but no other prostate cancer medications may have been given prior to enrolling in the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Lisa Bodei at 212-639-3146.

Protocol

22-134

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators