Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer

This study is a clinical trial to determine and assess the change in the rate of potency in
men with low-risk, localized, unilateral prostate cancer who have not received previous
treatment. A total of 86 men between 40 to 69 years of age with biopsy proven, early stage
localized prostate cancer will receive unilateral nerve-sparing cryoablation. The study
includes a screening/pre-operative visit, a cryoablation procedure day, and 10 follow up
visits over the course of 36 months. The first follow-up visit will occur within 2 weeks (±1
week) after cryoablation. Thereafter, follow-up visits will be scheduled, from the date of
procedure, every 3 months (±3 weeks) for 18 months and every 6 months (±3 weeks) thereafter
until the patient completes the protocol, 36 months after the cryoablation procedure.

Inclusion Criteria:

- Life expectancy >5 years

- Willing and able to freely sign informed consent to enroll in the study

- Willing to complete sexual function and HRQoL questionnaires

- Sexually active and potent (able to achieve an EPIC questionnaire sexual domain score
greater than or equal to 75 without the use of any devices or medicines to enhance
erections)

- Prostate gland volume greater than or equal to 20cc and less than or equal to 60cc

- Does not have stress urinary incontinence defined as urinary leakage requiring the use
of any protective pads

- Most recent serum PSA <10 ng/mL taken at least 6 weeks after a previous biopsy and 3
months +/- 2 weeks prior to study cryoablation

- Histologically proven, clinical stage T1c-T2b prostate cancer in the proposed treated
side

- Untreated contralateral side has no malignant elements demonstrated by biopsy

- Patient does not have ASAP (Atypical Small Acinar Proliferation) in the untreated side

- Patient has documented, biopsy proven unilateral disease (via a minimum of 6 biopsy
cores taken on the cancerous side and a minimum of 12 negative cores on the
non-cancerous side) using transrectal ultrasound (TRUS) guidance

- A 12 core biopsy using transrectal ultrasound (TRUS) guidance taken within 3 months
prior to enrollment from the non-cancerous side and each core was biopsied by a site
investigator

- Biopsied areas in the non-cancerous side include the following zones: L/R (left or
right side) lateral base, L/R mid gland base, L/R medial base, L/R lateral middle, L/R
mid gland middle, L/R medial middle, L/R lateral apex, L/R mid gland apex, L/R medial
apex, L/R transitional base, L/R transitional mid, L/R anterior horn

- Prostate biopsy Gleason Score (GS) is less than or equal to 7. Gleason Score 3+4=7
[but not 4+3=7] is allowed as long as the score is based upon no more than 2 cores
with cancer involvement of 50% or less.

- Does not have a biopsy GS 3+4=7 combined with clinical stage T2b

- Either a nodule was not felt (T1c) OR the palpable nodule (T2a or T2b) is on the same
side as the positive biopsy

Exclusion Criteria:

- Previous treatment for prostate cancer including radiation, cryoablation,
chemotherapy, surgery, high intensity focused ultrasound, and/or hormone therapy

- Previous invasive or minimally invasive treatment for benign prostatic hypertrophy
(BPH) (i.e., TURP, TUMPT, WIT, TUNA)

- Inability to tolerate a transrectal ultrasound

- Active urinary tract infection

- Evidence of metastatic disease

- Irreversible bleeding diathesis or other bleeding disorders

- Anatomic penile abnormalities precluding cryoablation

- Erectile dysfunction (EPIC Questionnaire sexual domain score <60) at baseline,
including the use of any erectile aid (PDE-5, etc) to increase the EPIC Questionnaire
(Appendix D) sexual domain score >75, without which the patient would not qualify for
the study

- Current or history within the past 6 months of alcohol and/or substance abuse which
would impair participation in the study

- Major medical disorder (i.e. uncontrolled diabetes, significant hepatic, renal, or
hematological disorders, recent stroke or myocardial infarction), in the opinion of
the urologist, is an illness or complication which is not consistent with the protocol
requirements

- Unwilling to undergo the necessary follow-up for the trial period

- Bilateral prostate cancer disease

- Significant median lobe of the prostate which would preclude an adequate cryoablation
procedure (based on the discretion of the urologist)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrythmia, or psychiatric illness/social situations which would limit compliance with
study requirements

- Known HIV or AIDS-related illness