Clinical trial NCT00772317: A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)
Official title: A Multicenter Clinical Study of the Sonablate® 450 (Sonablate) for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Prostate Cancer
Keywords: Recurrent
prostate cancer
ebrt
hifu
Lead sponsor: SonaCare Medical
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 117
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: absence of biochemical failure, defined as achieving a PSA nadir of ≤ 0.5 ng/mL within 12 months of treatment
timeFrame: 12 months post treatment
Secondary outcomes:
measure: negative prostate biopsy at the 12 month time point
timeFrame: 12 months post treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at University of California Los Angeles
state: California
city: Washington
country: United States
facility: Walter Reed National Military Medical Center (Military Personnel Only)
state: District of Columbia
city: Naples
country: United States
facility: Specialists in Urology, P.A.
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Jeffersonville
country: United States
facility: Metropolitan Urology, PSC
state: Indiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Case Medical Center
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE PA, LLP
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: CAN-AM
state: Ontario
Study officials:
affiliation: SonaCare Medical, LLC
name: Mark Carol, MD
role: STUDY_DIRECTOR
References: