• Colleen A Lawton, Michelle DeSilvio, W Robert Lee, Leonard Gomella, David Grignon, Michael Gillin, Gerard Morton, Thomas Pisansky, and Howard Sandler.
• Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, USA. clawton@radonc.mcw.edu
• Int. J. Radiat. Oncol. Biol. Phys. 2007 Jan 1; 67 (1): 39-47.

PurposeTo evaluate the effectiveness of transrectal ultrasound-guided permanent radioactive (125)I implantation of the prostate for organ-confined adenocarcinoma of the prostate compared with historical data of prostatectomy and external beam radiotherapy within a cooperative group setting.Methods And MaterialsPatients accrued to this study had histologically confirmed, locally confined, adenocarcinoma of the prostate with clinical Stage T1b, T1c, or T2a, no nodal or metastatic disease, prostate-specific antigen level of < or =10 ng/mL, and Gleason score of < or =6. All patients underwent transrectal ultrasound-guided radioactive (125)I permanent seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume.ResultsA total of 27 institutions accrued a total of 101 patients to this protocol, with no institution accruing >8 patients. Six patients were ineligible, leaving 95 properly entered as eligible in the study. The median follow-up was 5.3 years (range, 0.4-6.5 years). At 5 years, 5 patients had local failure, 1 had evidence of distant failure, and 6 (6%) had biochemical failure. The overall survival rate at 5 years was 96.7%. At last follow-up, no patient had died of prostate cancer or related toxicities. Eight patients had a maximal acute toxicity level of 3, and no patient had Grade 4 or 5 acute toxicity. During follow-up, 2 patients had maximal Grade 3 toxicity, both related to bladder issues, and no patient experienced Grade 4 or 5 toxicity.ConclusionThe results of this clinical protocol (a multi-institutional trial of brachytherapy for localized adenocarcinoma of the prostate) have demonstrated that this type of trial can be successfully completed through the Radiation Therapy Oncology Group. Biochemical disease-free survival was comparable with other brachytherapy published series and with the results after surgery and external beam radiotherapy.

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