Regional Cryoablation for Localized Adenocarcinoma of the Prostate
Cryotherapy (also called cryoablation) is an FDA approved treatment for prostate cancer. It
involves placing multiple needles within the prostate and freezing the prostate, which will
destroy both the cancerous and normal prostate tissue in a very controlled manner. It is
possible to treat less than the whole prostate by only freezing the area of the prostate
known to contain the cancer.
For this study, cryotherapy will be performed in a way similar to whole prostate
cryotherapy, except the entire prostate will not be frozen. For this study, only that
portion of the prostate with the most prostate cancer and the upper half of the opposite
side of location of the cancer in the prostate will be treated. All areas of cancer may not
Cryotherapy is performed under general anesthetic in the operating room. An ultrasound
probe is inserted into the rectum to monitor the tissue freezing. A urethral warmer is
inserted into the bladder through the penis to maintain the health of the urethra.
You will complete quality-of-life questionnaires before the prostate biopsy, and then at 3,
6, 12, 18, 24, 30, and 36 months after cryotherapy. The questionnaires will ask about your
general health and your urinary, bowel, and sexual functions. The questionnaire should take
about 15 minutes to complete each time.
Digital Rectal Exams and PCA3 Testing:
Before your cryotherapy and again before the biopsies at Months 6, 18 and 36 you will have a
digital rectal exam (feeling the prostate through your anus) to check the status of the
disease. You will also have digital rectal exams at Months 48 and 60 to check the status of
Urine will be collected after each digital rectal exam. This sample will be tested for
PCA3, which has been associated with prostate cancer.
You will have additional prostate biopsies at 6, 18, and 36 months after cryotherapy. About
12 biopsies samples will be collected each time from the same locations as during the
screening biopsy. If you have rising PSA levels or your doctor thinks it is necessary, you
and your doctor will discuss the need additional biopsies at Months 48 and 60.
This is an investigational study. Cryotherapy is FDA approved for the destruction of
tissue, including prostate tissue. For the treatment of prostate cancer, it is commonly
used to treat the entire prostate gland. This study is investigational because only a part
of the prostate gland will be treated, instead of the entire gland. Partial organ treatment
with cryotherapy is common for treatment of kidney, liver, and skin lesions.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Response (Result of biopsy at 6 months after therapy)
At 6-month, 18-month or 36-month post-treatment biopsy
John F. Ward, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|