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)

Journal Article · Thu Sep 01 04:00:00 EDT 2011 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2010.05.056· OSTI ID:21587707

Hunt, Daniel ^[1]; Lee, W Robert ^[2]; Gomella, Leonard ^[3]; Grignon, David ^[4]; Gillin, Michael ^[5]; Morton, Gerard ^[6]; Pisansky, Thomas M ^[7]; Sandler, Howard ^[8]

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1. RTOG Statistical Center, Philadelphia, PA (United States)
2. Radiation Oncology, Duke University School of Medicine, Durham, NC (United States)
3. Urology, Thomas Jefferson University, Philadelphia, PA (United States)
4. Pathology, Wayne State University, Detroit, MI (United States)
5. Radiation Oncology, MD Anderson Cancer Center, University of Texas, Houston, TX (United States)
6. Radiation Oncology, Toronto-Sunnybrook Regional Cancer Center, Toronto, ON (Canada)
7. Radiation Oncology, Mayo Clinic, Rochester, MN (United States)
8. Radiation Oncology, Cedar Sinai Medical Center, Los Angeles, CA (United States)

Purpose: To evaluate the long-term effectiveness of transrectal ultrasound-guided permanent radioactive I{sup 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. 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 I{sup 125} 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.

• OSTI ID: 21587707
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 1 Vol. 81; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ANTIGENS
BETA DECAY RADIOISOTOPES
BODY
BRACHYTHERAPY
CARCINOMAS
CLINICAL TRIALS
DAYS LIVING RADIOISOTOPES
DISEASES
DOSE RATES
DOSES
ELECTRON CAPTURE RADIOISOTOPES
GLANDS
INTERMEDIATE MASS NUCLEI
INTERNAL CONVERSION RADIOISOTOPES
IODINE 125
IODINE ISOTOPES
ISOTOPES
MALE GENITALS
MEDICINE
METASTASES
NEOPLASMS
NUCLEAR MEDICINE
NUCLEI
ODD-EVEN NUCLEI
ORGANS
PROSTATE
RADIATION DOSES
RADIOISOTOPES
RADIOLOGY
RADIOTHERAPY
SURGERY
TESTING
THERAPY
TOXICITY