Long-Term Results of an RTOG Phase II Trial (00-19) of External-Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate-Risk Clinically Localized Adenocarcinoma of the Prostate

Published:February 13, 2012DOI:


      External-beam radiation therapy combined with low—doserate permanent brachytherapy are commonly used to treat men with localized prostate cancer. This Phase II trial was performed to document late gastrointestinal or genitourinary toxicity as well as biochemical control for this treatment in a multi-institutional cooperative group setting. This report defines the long-term results of this trial.

      Methods and Materials

      All eligible patients received external-beam radiation (45 Gy in 25 fractions) followed 2–6 weeks later by a permanent iodine 125 implant of 108 Gy. Late toxicity was defined by the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. Biochemical control was defined by the American Society for Therapeutic Radiology and Oncology (ASTRO) Consensus definition and the ASTRO Phoenix definition.


      One hundred thirty-eight patients were enrolled from 20 institutions, and 131 were eligible. Median follow-up (living patients) was 8.2 years (range, 2.7–9.3 years). The 8-year estimate of late grade >3 genitourinary and/or gastrointestinal toxicity was 15%. The most common grade >3 toxicities were urinary frequency, dysuria, and proctitis. There were two grade 4 toxicities, both bladder necrosis, and no grade 5 toxicities. In addition, 42% of patients complained of grade 3 impotence (no erections) at 8 years. The 8-year estimate of biochemical failure was 18% and 21% by the Phoenix and ASTRO consensus definitions, respectively.


      Biochemical control for this treatment seems durable with 8 years of follow-up and is similar to high—dose external beam radiation alone or brachytherapy alone. Late toxicity in this multi-institutional trial is higher than reports from similar cohorts of patients treated with high—dose external-beam radiation alone or permanent low—doserate brachytherapy alone, perhaps suggesting further attention to strategies that limit doses to normal structures or to unimodal radiotherapy techniques.


      To read this article in full you will need to make a payment
      ASTRO Member Login
      ASTRO Members, full access to the journal is a member benefit. Use your society credentials to access all journal content and features.
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Purchase one-time access:

      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Dattoli M.
        • Wallner K.
        • True L.
        • et al.
        Long-term outcomes after treatment with external beam radiation therapy and palladium 103 for patients with higher risk prostate carcinoma.
        Cancer. 2003; 97: 979-983
        • Merrick G.S.
        • Butler W.M.
        • Wallner K.E.
        • et al.
        Impact of supplemental external beam radiotherapy and/or androgen deprivation therapy on biochemical outcome after permanent prostate brachytherapy.
        Int J Radiat Oncol Biol Phys. 2005; 61: 32-43
        • Taira A.V.
        • Merrick G.S.
        • Galbreath R.W.
        • et al.
        Natural history of clinically staged low and intermediate risk prostate cancer treated with monotherapeutic permanent interstitial brachytherapy.
        Int J Radiat Oncol Biol Phys. 2010; 76: 349-354
        • Zietman A.L.
        • Bae K.
        • Slater J.D.
        • et al.
        Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early stage adenocarcinoma of the prostate long term results from Proton Radiation Oncology Group/American College of Radiology 95-09.
        J Clin Oncol. 2010; 28: 1106-1111
        • Lee W.R.
        • DeSilvio M.
        • Lawton C.
        • et al.
        A Phase II study of external beam radiotherapy combined with permanent source brachytherapy for intermediate risk clinically localized adenocarcinoma of the prostate: Preliminary results of RTOG P-0019.
        Int J Radiat Oncol Biol Phys. 2006; 64: 804-809
      1. American Society for Therapeutic Radiology and Oncology Consensus Panel: Consensus statement: Guidelines for PSA following radiotherapy.
        Int J Radiat Oncol Biol Phys. 1997; 37: 1035-1041
        • Roach M.
        • Hanks G.
        • Thames H.
        • et al.
        Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: Recommendations of the RTOG-ASTRO Phoenix Consensus Conference.
        Int J Radiat Oncol Biol Phys. 2006; 65: 965-974
        • Kuban D.
        • Thames H.
        • Levy L.
        • et al.
        Long term multi-institutional analysis of Stage T1-T2 prostate cancer treated with radiotherapy in the PSA era.
        Int J Radiat Oncol Biol Phys. 2003; 57: 915-928
        • Zelefsky M.
        • Kuban D.
        • Levy L.
        • et al.
        Multi-institutional analysis of long-term outcome for states T1-T2 prostate cancer treated with permanent seed implantation.
        Int J Radiat Oncol Biol Phys. 2007; 67: 327-333
        • Talcott J.A.
        • Rossi C.
        • Shipley W.U.
        • et al.
        Patient-reported long term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer.
        JAMA. 2010; 303: 1046-1053
        • Michalski J.
        • Bae K.
        • Roach M.
        • et al.
        Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 94-06 Phase I/II dose escalation study.
        Int J Radiat Oncol Biol Phys. 2010; 76: 14-22
        • Lawton C.A.
        • Hunt D.
        • Lee W.R.
        • et al.
        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).
        Int J Radiat Oncol Biol Phys. 2011; 81: 1-7


      Commenting Guidelines

      To submit a comment for a journal article, please use the space above and note the following:

      • We will review submitted comments as soon as possible, striving for within two business days.
      • This forum is intended for constructive dialogue. Comments that are commercial or promotional in nature, pertain to specific medical cases, are not relevant to the article for which they have been submitted, or are otherwise inappropriate will not be posted.
      • We require that commenters identify themselves with names and affiliations.
      • Comments must be in compliance with our Terms & Conditions.
      • Comments are not peer-reviewed.