A Phase I/IIA Study of TRC253 in Patients with Metastatic Castration-Resistant Prostate Cancer


Full Title

253PC101: An Open-Label Phase 1/2A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TRC253, an Androgen Receptor Antagonist, in Patients with Metastatic Castration-Resistant Prostate Cancer


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).

The androgen receptor is a protein that is important in the development and progression of prostate cancer. TRC253 is an investigational drug designed to inhibit prostate cancer growth by blocking the androgen receptor. The purpose of this study is to evaluate the safety and effectiveness of TRC253 in men with metastatic CRPC.

In laboratory studies, TRC253 killed prostate cancer cells that no longer responded to other drugs that target the androgen receptor, such as abiraterone acetate and enzalutamide. It is hoped that TRC253 can make prostate cancer cells less resistant to standard therapies. TRC253 is taken orally (by mouth).


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 hormone therapy, such as abiraterone, enzalutamide, or apalutamide. Patients in the phase II portion of the study must have previously received enzalutamide or apalutamide.
  • An acceptable amount of time (several weeks, depending on the therapy) must pass between the completion of prior treatment and entry into 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. Dana Rathkopf at 646-422-4379.