Trial Information

Phase II Trial of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate

OBJECTIVES: I. Evaluate the effectiveness of transrectal ultrasound guided permanent
radioactive implantation of the prostate in patients with confined adenocarcinoma of the
prostate. II. Assess the overall survival, disease specific survival, clinical relapse
(local or distant), PSA levels, and genitourinary and gastrointestinal morbidity in these
implant patients. III. Assess the quality of life of these patients.

OUTLINE: This is a multicenter study. Patients receive transrectal ultrasound guided
radioactive I-125 seeds implanted into the prostate. At least one week prior to implant,
patients undergo transurethral ultrasound study to determine the volume of prostate.
Following implantation, seeds that have extruded into the bladder or lodged in the urethral
wall are retrieved, and extra seeds may be implanted into identified "cold spots" for
uniform seed distribution. Prostate rebiopsy is required before starting hormonal therapy
for local progression or biochemical failure without clear focus of progression. Quality of
life is assessed every 3 months for 1 year, then every 6 months for 1 year, and then
annually for 3 years. Patients are followed every 3 months for 1 year, then every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 1 year.