Radiation Oncology Medical College of Wisconsin, Milwaukee, WI.
To evaluate the long-term effectiveness of transrectal ultrasound-guided permanent radioactive I(125) 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.
Patients accrued to this study had histologically confirmed, locally confined adenocarcinoma of the prostate clinical stage T1b, T1c, or T2a; no nodal or metastatic disease; prostate-specific antigen level of ≤ 10 ng/ml; and a Gleason score of ≤ 6. All patients underwent transrectal ultrasound-guided radioactive I(125) seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume.
A total of 101 patients from 27 institutions were accrued to this protocol; by design, no single institution accrued more than 8 patients. There were 94 eligible patients. The median follow up was 8.1 years (range, 0.1-9.2 years). After 8 years, 8 patients had protocol-defined biochemical (prostate-specific antigen) failure (cumulative incidence, 8.0%); 5 patients had local failure (cumulative incidence, 5.5%); and 1 patient had distant failure (cumulative incidence, 1.1%; this patient also had biochemical failure and died of causes not related to prostate cancer). The 8-year overall survival rate was 88%. At last follow-up, no patient had died of prostate cancer or related toxicities. Three patients had maximum late toxicities of Grade 3, all of which were genitourinary. No Grade 4 or 5 toxicities were observed.
The long-term results of this clinical trial have demonstrated that this kind of trial can be successfully completed through the RTOG and that results in terms of biochemical failure and toxicity compare very favorably with other brachytherapy published series as well as surgical and external beam radiotherapy series. In addition, the prospective, multicenter design highlights the probable generalizability of the outcomes.
Written by:
Lawton CA, Hunt D, Lee WR, Gomella L, Grignon D, Gillin M, Morton G, Pisansky TM, Sandler H. Are you the author?
Reference: Int J Radiat Oncol Biol Phys. 2011 Apr 4. Epub ahead of print.
doi: 10.1016/j.ijrobp.2010.05.056
PubMed Abstract
PMID: 21470793
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