A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

The proposed study is a non-randomized, prospective, single arm study. The safety and
effectiveness of the Sonablate treatment in subjects with locally recurrent prostate cancer
will be evaluated with regard to freedom from biochemical failure and disease recurrence
following HIFU treatment.

Men with histologically confirmed, locally recurrent, organ-confined, non-metastatic
prostatic adenocarcinoma two or more years following EBRT, PSA ≥0.5 ng/mL and ≤10 ng/mL, 40
to 85 years of age, and with initial staging of T1c-T2 prior to radiation, who meet the
criteria for salvage treatment, will be enrolled.

This pivotal study will cover pre-treatment through the 12-month post-treatment follow-up
visit (8 visits).

A 5 year extended follow-up study will be conducted annually for the 2nd-5th years post
treatment (4 additional visits).

Inclusion Criteria:

- subjects with initial presentation of organ confined recurrent prostate cancer
(Stages T1c and T2 only) who have been treated with EBRT (conventional, 3D conformal,
or IMRT) or proton therapy, two or more years prior, and currently have biopsy proven
local recurrence. Previous radiation therapy must be a documented therapeutic dose of
60 to 81Gy or GyE (gray equivalent) for proton therapy;

- Negative bone scan within 6 months prior to enrollment to rule out possibility of
metastases;

- Negative CT scans of the chest, abdomen, and pelvis within 6 months prior to
enrollment to rule out possibility of metastases;

- age ≥40 years through ≤85 years of age;

- prostate biopsy with ≥10 core biopsies demonstrating 1 or more cores positive for
cancer cells, within 6 months prior to treatment;

- prostate volume ≤ 40 gms(cc) (HIFU subject prostate volume will be initially
calculated utilizing TRUS measurements during screening and verified with the use of
the Sonablate before initiating the HIFU procedure. Patients with prostate volumes
greater than 40 gm(cc) as determined by either measurement will not be enrolled in
the study);

- AP diameter of the prostate must be ≤4.0cm;

- serum prostate specific antigen (PSA) ≥0.5 ng/mL and ≤10 ng/mL;

- >90 days post hormone therapy usages, subjects who have or are currently undergoing
hormone therapy (GnRH agonist/antagonist) must discontinue hormone therapy and go
through a 90 day washout period prior to consideration for study participation, and
must remain off hormone therapy throughout the duration of the follow-up period (5
years);

- signed informed consent for the HIFU treatment study through the 12 month follow-up
visit (7 visits) and then through the extended follow-up period of 5 years (4
additional visits);

- life expectancy > 12 months.

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) criteria of IV or higher;

- intra-prostatic calcifications >1.0 cm (single or continuous grouping) on 2 or more
consecutive images along the same plane by either the TRUS or Sonablate 500
measurement will not be enrolled;

- active, uncorrected bleeding disorder as determined by abnormal prothrombin time,
partial thromboplastin time, or INR at the time of HIFU (use international lab normal
ranges for parameters);

- use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily
reversed or stopped;

- active urinary tract infection;

- interest in future fertility;

- body weight which would preclude proper suprapubic catheter functioning, per
investigator's discretion

- inability to visualize the prostatic tissue adequately on transrectal ultrasound
imaging;

- use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride
(Proscar) or Dutasteride (Avodart);

- a debulking transurethral resection of the prostate (TURP) is not acceptable once the
screening biopsy for patient selection has been conducted;

- prior treatment for prostate cancer, other than EBRT or hormone therapy;

- history of urethral stent or urethral surgery (urethral dilation, urethroplasty); a
Uroflow exam may be conducted at the investigators discretion;

- prior significant rectal surgery (hemorrhoidectomy is acceptable; rectal
resection/fissure repair are excluded);

- history of inflammatory bowel disease of the rectum;

- history of any other malignancy treated within the last 5 years, other than squamous
or basal cell skin cancer;

- functional bladder problems defined as IPSS > 19;

- current bladder cancer, urethral stricture, or bladder neck contracture; a cystoscopy
my be performed at the investigator's discretion to rule out these conditions;

- urinary tract or rectal fistula;

- rectal fibrosis/stenosis; anoscopy or proctoscopy may be performed at the
investigator's discretion;

- anomaly of the rectal anatomy or mucus membrane; anoscopy or proctoscopy may be
performed at the investigator's discretion;

- prostate seroma/abscess;

- current symptomatic radiation proctitis requiring creams;

- participation in other investigational studies, unless approved in writing by the
study sponsor.