A Phase III Study of 177LU-PSMA-617 for PSMA-Positive Advanced Prostate Cancer

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VISION: An International, Prospective, Open-label, Multicenter, Randomized Phase 3 Study of 177LU-PSMA-617 in the Treatment of Patients with Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).

177LU-PSMA-617 is a type of therapy called “radionuclide therapy.” It combines a radiation-emitting metal (Lutetium 177 or 177Lu) with a tumor-targeting agent (PSMA) to deliver radiation directly into a tumor and destroy cancer cells. 177LU-PSMA-617 travels through the blood to reach cells throughout the body. 177LU-PSMA-617 targets tumor cells that carry PSMA, like prostate cancer cells, but it “ignores” most healthy cells that are unrelated to prostate tissue.

In this study, researchers are determining if adding 177LU-PSMA-617 to standard therapy for metastatic CRPC is more effective than standard therapy alone. Patients in this study will be randomly assigned to receive 177LU-PSMA-617 plus standard/supportive therapy or standard/supportive therapy alone. 177LU-PSMA-617 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic CRPC that is positive for PSMA and has already been treated with a drug like enzalutamide or abiraterone, as well as one or two regimens of therapy that included a taxane (such as docetaxel).
  • At least 6 months must pass since any prior radionuclide therapy and 4 weeks since chemotherapy or immunotherapy and entry into 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 patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Morris at 646-422-4469.

Protocol

18-470

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators