Clinical Trials

A Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Low-Risk Prostate Cancer

Protocol
11-056
Full Title
Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage Low Volume Prostate Cancer
Purpose

Brachytherapy is a method of treating low-risk prostate cancer: a small amount of cancer in a small area of the gland. It involves implanting tiny radioactive seeds in the prostate. Conventionally, the seeds are implanted throughout the entire prostate gland. This approach to treatment is an alternative to surgery to remove the prostate, but may also be associated with urinary, sexual, and bowel side effects.

Focal therapy is a form of brachytherapy in which the seeds are only implanted in or near the parts of the prostate that contain cancer cells. It may have fewer side effects because it does not target the entire prostate gland. It is an option for men with low-risk prostate cancer who do not want surgery or conventional whole-gland brachytherapy, but also do not want “watchful waiting” (giving no treatment and just monitoring the cancer’s growth).

In this study, researchers want to assess the effectiveness of focal brachytherapy in men with low-risk prostate cancer, determine what side effects it may cause, and evaluate the effect of the treatment on patients’ quality of life.

Investigator
Michael J. Zelefsky, MD -- Vice Chair for Clinical Research, Department of Radiation Oncology; Chief, Brachytherapy Service
Michael J. Zelefsky - Physician Profile
Eligibility

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

  • Patients must have low-risk prostate cancer (stage T1c-T2a).
  • No more than 25 percent of biopsy cores may contain cancer, and no more than 50 percent of a core may contain cancer. The cancer must be confined to one side of the prostate.
  • 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.
  • Patients must be age 21 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Zelefsky at 212-639-6802.

Disease(s)
Prostate Cancer
Prostate Cancer: Localized Disease
Locations
ClinicalTrials.gov
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