A Phase I Study of DSTP3086S in Patients with Metastatic Castration-Resistant Prostate Cancer

Protocol
11-016
Full Title
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients with Metastatic Castration-Resistant Prostate Cancer
Phase
I
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 (“castration-resistant” prostate cancer).

Anticancer drugs such as docetaxel and cabazitaxel may be used in men with castration-resistant disease. But while these drugs can slow cancer growth, they do not cure the cancer. Doctors are therefore continuing to search for more effective treatments for men with advanced prostate cancer.

The purpose of this study is to find the highest dose of an investigational drug called DSTP3086S that can be given safely in men with metastatic castration-resistant prostate cancer who cannot be treated with standard therapy or who elect not to have standard chemotherapy. DSTP3086S is an antibody bound to a chemotherapy drug. The antibody targets prostate cancer cells, and delivers the anticancer drug directly to those cells to kill them.

Eligibility

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

  • Patients must have metastatic castration-resistant prostate cancer that cannot be treated with standard therapies, or elect not to have standard chemotherapy.
  • At least 4 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Daniel Danila at 646-422-4612.

Disease(s)
Prostate Cancer
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
Related Diseases