Radiation Oncology/RTOG Trials/0232

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  • Title: A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma
  • Objective: To evaluate the benefit in terms of overall survival of external beam radiation in addition to interstitial brachytherapy versus interstitial brachytherapy alone among selected patients with intermediate risk prostatic carcinoma.
  • Protocol:
    • Arm 1: 45 Gy EBRT + 2 weeks later Pd-103 (100 Gy) or I-125 (110 Gy)
    • Arm 2: Pd-103 (100 Gy) OR I-125 (110 Gy)
  • Eligibility:
    • cT1c-T2b
    • (GS 7 and PSA <10) or (GS <7 and PSA 10-20)
    • N0M0
    • TRUS volume <60cc
  • Enrollment Target: 1520 patients
  • Activation: June 11, 2003
  • Additional Information:
    • Meeting Minutes January 2005 - "Dr. Brad Prestidge updated the group on RTOG 0232. This randomized trial has had slow accrual to date. The projected monthly accrual was 25.3 cases per month and the average monthly accrual for the past six months was 6.8 cases per month. We discussed the possibility the credentialing process is an obstacle to registering patients on a trial. It was pointed out the number of institutions credentialed exceeds 50 and the RPC and ITC were working on methods to reduce the burden of the credentialing process. In addition, two more treatment-planning systems are now able to allow institutions to participate in a clinical trial (Rosses and RTek). There was a brief discussion about hormone therapy being allowed on the protocol and as it stands up to two months of hormone therapy is allowed prior to registration. Patients may receive six months of hormone therapy. Finally, it was agreed IMRT be allowed on this trial. For the purpose of this study central Quality Assurance of the IMRT is not allowed. Institutions have the option of either being credentialed using IMRT for any of the RTOG studies using the RPC Phantom or using the QARC Benchmark tool."
    • Meeting Minutes June 2004 - "Dr. Prestige announced accrual remains slow on RTOG 0232 – the randomized study for brachytherapy plus external beam radiation therapy versus brachytherapy alone for early stage prostate cancer. He encouraged institutions to get credentialed for electronic data submission of permanent brachytherapy treatment plans. Dr. Michalski pointed out there was some interest from institutions in the UK to participate."
  • Publications:
    • No Abstract - Urinary and rectal complications of contemporary permanent transperineal brachytherapy for prostate carcinoma with or without external beam radiation therapy (Prestidge BR, Cancer 2005)
  • ASTRO 2016:
    • ASTRO 2016 plenary PFS rate at five years post-treatment was 85 percent for EBT+B patients and 86 percent for B patients (Hazard Ratio, HR, 1.02; futility p = 0.0006). Overall toxicity levels were similar across groups only for acute side effects (i.e., those that occur closely following treatment), with eight percent of patients in each cohort reporting acute grade 3+ side effects. Late severe toxicities were more common for EBT+B patients (12 percent) than for B patients (7 percent), as were severe GU side effects GU (7 vs. 3 percent) and severe GI toxicities (3 vs. 2 percent).
    • Conclusion: Among men with intermediate risk (IR) prostate cancer, the addition of external beam therapy to brachytherapy did not result in superior freedom from progression compared to brachytherapy alone at 5 years in this initial report.
    • Implications for clinical practice: Men with intermediate risk prostate cancer may be well managed with brachytherapy alone.