Radiation Oncology/RTOG Trials/9020


  • Title: A Phase II Trial of External Beam Radiation With Etanidazole for Locally Advanced Prostate Cancer
  • Objectives:
    • (1) Determine the clinical complete response rate (as evidenced by clinical exam and reduction in PSA level to below 10 ng) following standard external beam irradiation plus etanidazole in patients with locally advanced prostate cancer.
    • (2) Evaluate disease-free survival, duration of response, and overall time to complete response in order to determine the endpoint that most sharply defines the long-term success of treatment.
    • (3) Determine the safety (i.e., absence of acute and chronic complications) of etanidazole given with whole-pelvis external beam irradiation in patients with locally advanced prostate cancer.
  • Protocol_NCI: EBRT + radiosensitization with Etanidazole
  • Eligibility: T2b-T4, M0
  • Enrolled: 36 patients
  • Conclusion:
    • PMID 8948352 -- Results of a phase II trial of external beam radiation with etanidazole (SR 2508) for the treatment of locally advanced prostate cancer (RTOG Protocol 90-20). (Lawton CA, IJRBOP 1996). Conclusion: Results of this trial regarding PSA response and clinical disappearance of disease are similar to historical controls and do not warrant further investigation of etanidazole as was done in this trial. Drug toxicity that, in the past, has been unacceptably high with other hypoxic cell sensitizers does not appear to be a significant problem with this drug.
  • Publications:
    • Bruner DW, Scott CB, McGowan D, et al.: Validation of the sexual adjustment questionnaire (SAQ) in prostate cancer patients enrolled on Radiation Therapy Oncology Group studies 90-20 and 94-08. Int J Radiat Oncol Biol Phys 42(suppl 1): A156, 202, 1998.
    • Bruner D, Scott C, McGowan D, et al.: Factors influencing sexual outcomes in prostate cancer patients enrolled on radiation therapy oncology group studies 90-20 and 94-08. [Abstract] Proceedings of the International Society for Quality of Life Research 7: 575, 1998.
    • PMID 7591900 -- RTOG's first quality of life study--RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer. (Watkins-Bruner D, IJRBOP 1995). Conclusion: Quality of life assessments are necessary and attainable in RTOG clinical trials. Compliance rates for both institutional and patient participation were acceptable at initial and 3 month follow-up. Reasons for noncompliance were predominantly institution related and not patient related. Strategies to address both institution and patient compliance have been developed and implemented within the RTOG. Serious disagreement between patient self-reports of symptoms on the FACT QL scale and medical professional ratings on the RTOG acute toxicity rating scales of the same symptoms was 13% at 3 months follow-up. This warrants continued use of QL self-assessments in clinical trials.
    • Bruner DW, Scott C, Byhardt R, Coughlin C, Friedland J, DelRowe J. Changes in urinary function (CUF): Pilot data on the development and validation of a measure of the intrusion on quality of life caused by changes in urinary function after cancer therapy, (RTOG 91-16, 90-20). Presented at the Drug Information Association 2nd Symposium on Quality of Life Evaluation, Charleston, SC, 1994.