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.