Clinical trial NCT00770822: Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
Official title: A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Primary
Prostate
Cancer
Primary T1c/T2a organ confined prostate cancer
organ-confined
Lead sponsor: SonaCare Medical
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 466
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.

Detailed description: The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.

Eligibility criteria: Inclusion Criteria:

* T1c or T2a carcinoma of the prostate confirmed by biopsy;
* life expectancy of 5(five) years or more;
* prostate biopsy with 10(ten) or more core biopsies;
* Gleason score of 6(six) or less;
* serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
* prostate volume of less than 40(Forty)cc;
* distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
* informed consent for the treatment study through 24 months post-treatment follow-up

Exclusion Criteria:

* men who have had previous definitive treatment for prostate cancer;
* evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
* prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
* inability to tolerate a transrectal ultrasound;
* active urinary tract infection;
* functional bladder problems;
* prior significant rectal surgery;
* intra-prostatic calcifications greater than 1(One)cm in diameter;
* interest in future fertility;
* prostatic surgery/procedure (except biopsy) within 1(One) year;
* large median lobe of the prostate;
* use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto);
* current bladder cancer, urethral stricture, or bladder neck contracture;
* urinary tract and/or rectal fistula;
* rectal fibrosis/stenosis;
* anomaly of the rectal anatomy or mucus membrane;
* prostate seroma/abcess;
* prostatitis;
* compromised renal function or upper urinary tract disease secondary to urinary obstruction;
* bleeding disorders/coagulopathy based on measures of PT and PTT;
* implant in the prostate or within 1(One)cm of the prostate;
* zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study

Primary outcomes:
measure: The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brachytherapy Site: Urology Centers of Alabama
state: Alabama
city: Naples
country: United States
facility: Brachytherapy Site: Specialists in Urology
state: Florida
city: Myrtle Beach
country: United States
facility: Brachytherapy Site: Grand Strand Urology
state: South Carolina
city: Memphis
country: United States
facility: HIFU Site: Southeast Urology Network
state: Tennessee
city: Nashville
country: United States
facility: HIFU Site: Urology Associates
state: Tennessee
city: San Antonio
country: United States
facility: HIFU Site: Urology of San Antonio
state: Texas
Study officials:
affiliation: Johns Hopkins Medical Institution
name: Mark Schoenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: