A Phase I Study of the Radiopharmaceutical 131I-MIP-1095 in Men with Advanced Prostate Cancer

Full Title

A Phase 1, Open-Label, Dose Ascending Study to Evaluate the Safety and Tolerability of the Therapeutic Radiopharmaceutical 131I-MIP-1095 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC)


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 (and are called “castration-resistant” prostate cancer, or CRPC). Additional hormonal therapies (enzalutamide and abiraterone) and chemotherapy drugs (docetaxel and cabazitaxel) are treatments for CRPC, but the cancer often eventually grows despite these therapies as well.

In this study, researchers are assessing the safety and best dose of the investigational drug 131I-MIP-1095. This drug is called a radiopharmaceutical. It consists a radioactive substance (radioactive iodine, which is also used to treat thyroid cancer) bound to a molecule that attaches to a protein on prostate cancer cells called PSMA. The molecule zeroes in on prostate cancer cells and delivers the radioactive iodine there, releasing it to kill cancer cells.


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

  • Patients must have metastatic CRPC that has continued to grow despite prior treatment with enzalutamide and/or abiraterone.
  • Patients must recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

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