Status:
UNKNOWN
Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
Lead Sponsor:
SonaCare Medical
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
NA
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00770822
Start Date
April 1 2007
End Date
December 1 2020
Last Update
April 10 2019
Active Locations (6)
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1
Brachytherapy Site: Urology Centers of Alabama
Birmingham, Alabama, United States, 35209
2
Brachytherapy Site: Specialists in Urology
Naples, Florida, United States, 34102
3
Brachytherapy Site: Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
4
HIFU Site: Southeast Urology Network
Memphis, Tennessee, United States, 38119