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A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer

[Protocol 08-118]

Full Title :
A PHASE II STUDY OF FOCAL CRYOABLATION IN LOW-RISK PROSTATE CANCER
Purpose :

Prostate cancer is relatively slow growing; it can take two to four years for a cancer to double in size. Some prostate cancers are so small that they pose little risk to the life or health of the patient. On the other hand, the rate at which a cancer will grow is difficult to predict, so most doctors recommend aggressive treatment of the entire prostate with either surgery or radiation therapy -- even for small cancers.

However, some men have a small cancer on only one side of the prostate (called "focal cancer") which may not require that the whole prostate gland be treated with radical prostatectomy (removal of the prostate), brachytherapy (inserting radioactive seeds), or external beam radiation therapy (radiation beams aimed at the prostate).

The purpose of this study is to evaluate the effectiveness and side effects of an approach called focal cryoablation (focal cryotherapy) for treating men with such low-risk focal prostate cancer. During this procedure, the small amount of cancer within the prostate is treated by freezing, and then the area is evaluated to be sure the cancer is gone so that no further therapy would be needed.

Eligibility :

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

  • Patients must have newly diagnosed, previously untreated stage T1c focal prostate cancer (on one side of the prostate only).
  • The prostate size must be less than 60 cc and the PSA level must be less than 10 ng/mL.
  • 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 and to inquire about eligibility for this study, please contact Dr. James Eastham at 646-422-4390.

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