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Title: Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (Radiation Therapy Oncology Group 98-05)

Abstract

Purpose: To evaluate the effectiveness of transrectal ultrasound-guided permanent radioactive {sup 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 Materials: Patients 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 {<=}10 ng/mL, and Gleason score of {<=}6. All patients underwent transrectal ultrasound-guided radioactive {sup 125}I permanent seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume. Results: A 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 nomore » 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. Conclusion: The 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 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.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9]
  1. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States). E-mail: clawton@radonc.mcw.edu
  2. Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, PA (United States)
  3. Department of Radiation Oncology, Wake Forest University School of Medicine, Winston-Salem, NC (United States)
  4. Department of Urology, Thomas Jefferson University, Philadelphia PA (United States)
  5. Department of Pathology, Wayne State University, Detroit, MI (United States)
  6. Department of Radiation Oncology, M.D. Anderson Cancer Center, Houston, TX (United States)
  7. Department of Radiation Oncology, Toronto-Sunnybrook Regional Cancer Center, Toronto, ON (Canada)
  8. Department of Radiation Oncology, Mayo Clinic, Rochester, MN (United States)
  9. Department of Radiation Oncology, University of Michigan, Ann Arbor, MI (United States)
Publication Date:
OSTI Identifier:
20850292
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 67; Journal Issue: 1; Other Information: DOI: 10.1016/j.ijrobp.2006.08.016; PII: S0360-3016(06)02763-5; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ANTIGENS; BEAMS; BLADDER; BRACHYTHERAPY; CARCINOMAS; FAILURES; IODINE 125; METASTASES; PATIENTS; PROSTATE; RADIATION DOSES; RADIATION SOURCE IMPLANTS; SURGERY; TOXICITY

Citation Formats

Lawton, Colleen A., DeSilvio, Michelle, Lee, W. Robert, Gomella, Leonard, Grignon, David, Gillin, Michael, Morton, Gerard, Pisansky, Thomas, and Sandler, Howard. Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (Radiation Therapy Oncology Group 98-05). United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.08.016.
Lawton, Colleen A., DeSilvio, Michelle, Lee, W. Robert, Gomella, Leonard, Grignon, David, Gillin, Michael, Morton, Gerard, Pisansky, Thomas, & Sandler, Howard. Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (Radiation Therapy Oncology Group 98-05). United States. doi:10.1016/j.ijrobp.2006.08.016.
Lawton, Colleen A., DeSilvio, Michelle, Lee, W. Robert, Gomella, Leonard, Grignon, David, Gillin, Michael, Morton, Gerard, Pisansky, Thomas, and Sandler, Howard. Mon . "Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (Radiation Therapy Oncology Group 98-05)". United States. doi:10.1016/j.ijrobp.2006.08.016.
@article{osti_20850292,
title = {Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (Radiation Therapy Oncology Group 98-05)},
author = {Lawton, Colleen A. and DeSilvio, Michelle and Lee, W. Robert and Gomella, Leonard and Grignon, David and Gillin, Michael and Morton, Gerard and Pisansky, Thomas and Sandler, Howard},
abstractNote = {Purpose: To evaluate the effectiveness of transrectal ultrasound-guided permanent radioactive {sup 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 Materials: Patients 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 {<=}10 ng/mL, and Gleason score of {<=}6. All patients underwent transrectal ultrasound-guided radioactive {sup 125}I permanent seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume. Results: A 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. Conclusion: The 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 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.},
doi = {10.1016/j.ijrobp.2006.08.016},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 1,
volume = 67,
place = {United States},
year = {Mon Jan 01 00:00:00 EST 2007},
month = {Mon Jan 01 00:00:00 EST 2007}
}