Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer

Inclusion Criteria:

- Diagnosis of prostate cancer confirmed by PSA and prostate biopsy

- Male subjects, aged equal to or over 50 years

- Organ-confined prostate cancer, clinical stage T1a, b, or c or T2a

- At least one positive biopsy within the previous 6 months

- PSA equal to or less than 10 ng/ml

- Gleason score equal to or less than 6

- Histological grading of 3+3, 3+2, 2+3, 2+4, or 2+2 based upon the baseline
transrectal ultrasound (TRUS)-guided 10 core biopsy results. A subject with a
histological grading of primary 4 will not be permitted for study enrollment.

- Prostate volume equal to or less than 40 cc

- Prostate anteroposterior (AP) diameter equal to or less than 25 mm

- Normal rectal anatomy and rectal mucosa

- Maximum rectal wall measurement 6 mm

- The Investigator has completed a medical history and a physical examination to assure
that the subjects meet all study enrollment criteria

- The subject is willing and able to read, understand, and sign the study specific
informed consent form

- The subject agrees to comply with study protocol requirements, including HIFU or
cryotherapy treatment and all follow up visit requirements through 24 months of
follow up treatment.

Exclusion Criteria:

- Evidence of seminal vesicle involvement

- Evidence of lymph node involvement or metastasis

- Any previous treatment for prostate cancer including: external beam radiation therapy
(EBRT), hormone therapy and/or previous bilateral orchiectomy

- Previous surgery or procedure of the prostate (except prostate biopsy) or urethra
within the prior one year

- Calcification inducing a shadow in the prostate which cannot be included in the
targeted volume

- Large median lobe of the prostate which cannot be included in the target volume

- Use within the previous 2 months of finasteride

- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease

- Active inflammatory bowel syndrome

- Current superficial bladder cancer, urethral stricture, or bladder neck contracture

- Active urinary tract infection or prostatitis (the subject may be enrolled once the
infection has been treated and has resolved)

- Compromised renal function or upper urinary tract disease as a result of urinary
obstruction

- A history of bleeding disorders/coagulopathy or ongoing treatment for this condition

- Urinary tract or rectal fistula

- Rectal fibrosis, rectal stenosis, or other anomalies making the Ablatherm Integrated
Imaging rectal probe insertion difficult

- Anatomical anomaly of the rectum or anomaly of the rectal mucous membrane

- Prostate seroma, prostate abscess, or urethral stenosis

- An intraprostatic implant such as a stent or catheter, or any implant or prosthesis
at less than 1 cm from the prostate

- Interest in future fertility

- Concurrent illness, disability, or geographical residence would hamper attendance at
required study visits

- Known latex hypersensitivity

- Current participation in another clinical investigation of a medical device or a drug
or has participated in such a study within 30 days prior to study enrollment

- The Investigator believes that the subject will be unwilling or unable to comply with
study protocol requirements, including the HIFU or cryotherapy procedure and
study-related follow up visit requirements.