Prostate Conformal Cryotherapy

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 be treated.

Cryotherapy:

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.

Quality-of-Life Questionnaires:

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
the disease.

Urine will be collected after each digital rectal exam. This sample will be tested for PCA3,
which has been associated with prostate cancer.

Prostate Biopsies:

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.

Inclusion Criteria:

1. Histologically identified adenocarcinoma of the prostate by minimum 6 core prostate
biopsy.

2. Serum PSA
3. Less than 50% of samples from one side of the prostate positive for prostate cancer.

4. No greater than 50% of a single core total length occupied by prostate cancer.

5. No dominant Gleason 4 component. (e.g.; 4+X is not allowed, but X+4 is eligible)

6. No Gleason 5 component (primary, secondary or tertiary).

7. Subjects may have contralateral positive prostate biopsy in a single core within the
eligibility biopsy so long as the involvement of this core is 2mm or less and no
Gleason 4 or Gleason 5 pattern exists. This is considered to be Non-Dominant
(Contralateral) Tumor Burden and is not exclusionary.

8. In the case that the confirmatory biopsy fails to sample the tumor again, patients
will be allowed to continue into the therapeutic phase using the laterality
information obtained during the eligibility biopsy.

Exclusion Criteria:

1. Medical History or Concurrent Disease which in the investigators mind places the
patient at significant preoperative risk or for which the investigator does not feel
this therapy is appropriate. Investigator believes subject is unwilling or unable to
comply with study protocol requirements.

2. AUASI (American Urologic Association Symptom Index) score >/=20

3. Active urinary tract infection

4. Active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped
at the time of prostate biopsy and cryotherapy.

5. Medical or surgical castration initiated before or after the eligibility biopsy.

6. Patient is unable to provide informed consent.

7. Patients will undergo base line bone scan prior to cryoablation to evaluate for
regions of abnormal uptake before therapeutic intervention. Metastatic disease by bone
scintigraphy is exclusionary. Bone scans performed within 12 months prior to study
entry will be used for study base line purposes and will not need to be repeated,
unless clinically indicated.