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

Sponsor

SonaCare Medical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00772317

Collaborator

(none)

117

Enrollment

Locations

Arm

161

Duration (Months)

7.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT)

Condition or Disease	Intervention/Treatment	Phase
Recurrent Prostate Cancer	Device: High Intensity Focused Ultrasound	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIFU High Intensity Focused Ultrasound	Device: High Intensity Focused Ultrasound High Intensity Focused Ultrasound Other Names: Sonablate 450 Sonablate

Arm

Intervention/Treatment

Experimental: HIFU

High Intensity Focused Ultrasound

Device: High Intensity Focused Ultrasound

High Intensity Focused Ultrasound

Other Names:

Sonablate 450

Sonablate

Outcome Measures

Primary Outcome Measures

absence of biochemical failure, defined as achieving a PSA nadir of ≤ 0.5 ng/mL within 12 months of treatment [12 months post treatment]

Secondary Outcome Measures

negative prostate biopsy at the 12 month time point [12 months post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tower Urology	Los Angeles	California	United States	90048
2	David Geffen School of Medicine at University of California Los Angeles	Los Angeles	California	United States	90095
3	Walter Reed National Military Medical Center (Military Personnel Only)	Washington	District of Columbia	United States	20307
4	Specialists in Urology, P.A.	Naples	Florida	United States	34102
5	Indiana University	Indianapolis	Indiana	United States	46202
6	Metropolitan Urology, PSC	Jeffersonville	Indiana	United States	47130
7	Tulane University	New Orleans	Louisiana	United States	70112
8	New York University School of Medicine	New York	New York	United States	10016
9	University of Cincinnati	Cincinnati	Ohio	United States	45206
10	University Hospitals of Cleveland Case Medical Center	Cleveland	Ohio	United States	44106
11	Urologic Consultants of SE PA, LLP	Bala-Cynwyd	Pennsylvania	United States	19004
12	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
13	University of Texas M.D. Anderson Cancer Center	Houston	Texas	United States	77030
14	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792
15	London Health Sciences Centre	London	Ontario	Canada	N6A 4G5
16	CAN-AM	Toronto	Ontario	Canada	M6A 3B5