Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2011 Sep 1;81(1):1-7.
doi: 10.1016/j.ijrobp.2010.05.056. Epub 2011 Apr 4.

Long-term results of a phase II trial of ultrasound-guided radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (RTOG 98-05)

Colleen A Lawton  1 , Daniel Hunt, W Robert Lee, Leonard Gomella, David Grignon, Michael Gillin, Gerard Morton, Thomas M Pisansky, Howard Sandler
Affiliations
Clinical Trial

Long-term results of a phase II trial of ultrasound-guided radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (RTOG 98-05)

Colleen A Lawton et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: To evaluate the long-term effectiveness of transrectal ultrasound-guided permanent radioactive I125 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 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 I125 seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume.

Results: 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.

Conclusions: 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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None

Figures

Figure 1
Figure 1
Biochemical Failure According to Protocol Definition and RTOG Phoenix Definition
Figure 2
Figure 2
Time to Local Failure
Figure 3
Figure 3
Overall Survival
Figure 4
Figure 4
Time to Late Toxicity
See this image and copyright information in PMC

References

    1. Lawton CA, DeSilvio M, Lee WR, et al. 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 (RTOG 98-05) Int J Rad Onc Biol & Phys. 2007;67(1):39–47. - PubMed
    1. Feigenberg SJ, Lee WR, DeSilvio ML, Winter K, Pisansky TM, Bruner DW, Lawton C, Morton G, Baikadi M, Sandler H. Health-Related Quality of Life In Men Receiving Prostate Brachytherapy on RTOG 98–05. Int J Radiat Oncol Biol Phys. 2005;62 (4):956–964. - PubMed
    1. Dose and Volume Specification for Reporting Interstitial Therapy. International Commission on Radiation Units and Measurements; Bethesda, MD: 1997. ICRU Report 58.
    1. AAPM Report #51. Dosimetry of Interstitial Brachytherapy Sources, Reprinted from Medical Physics. 1995 February;22(2):209–234. - PubMed
    1. Cancer Therapy Evaluation Program (CTEP) Feb 26, 2010. Web. < http://ctep.info.nih.gov/protocolDevelopment/electronic_applications/ctc...>.

MeSH terms

Substances

LinkOut - more resources