Phase I/II trial of high intensity focused ultrasound for the treatment of previously untreated localized prostate cancer.
OBJECTIVE
We examined the safety and potential efficacy of transrectally delivered high intensity focused ultrasound for the full gland ablation of previously untreated localized prostate cancer.


METHODS
A total of 20 patients with localized prostate cancer underwent 1 to 3 high intensity focused ultrasound treatments of the prostate. The primary outcome was safety and the secondary outcomes were prostate specific antigen, prostate biopsy and quality of life measures.


RESULTS
A total of 19 patients had complete followup. Serious adverse events related to treatment were limited with the most common adverse event being transient urinary retention more than 30 days in duration in only 10% of patients. Rectal injury occurred in 1 patient. With 1 to 3 treatments 42% of the patients achieved prostate specific antigen less than 0.5 ng/ml and a negative prostate biopsy.


CONCLUSIONS
High intensity focused ultrasound in patients with previously untreated prostate cancer is generally well tolerated and it has the potential to completely ablate the prostate gland. With further refinement of the optimal treatment dose and technique this technology has the potential to be an effective form of therapy for localized prostate cancer.
Koch
Michael O
MO
Department of Urology, Indiana University School of Medicine and Focus Surgery, Inc., Indianapolis, Indiana 46202, USA. miokoch@iupui.edu
Gardner
Thomas
T
Cheng
Liang
L
Fedewa
Russell J
RJ
Seip
Ralf
R
Sanghvi
Narendra T
NT
Sangvhi
Narendra T
NT
D000368:Aged; D001707:Biopsy, Needle; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging* / Q000628:therapy*; D018570:Risk Assessment; D016896:Treatment Outcome; D014463:Ultrasonography; D036761:Ultrasound, High-Intensity Focused, Transrectal / Q000379:methods*
D017430:Prostate-Specific Antigen