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Protocol No. RTOG0924

Principal Investigator Cooley, Gregory

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Objective The purpose of this study is to compare the effects of hormone therapy (androgen deprivation)and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area on you and your prostate cancer to find out which is better.

Treatment
There are 2 treatment groups in this study:
  • Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles (two small glands behind the prostate)
  • Patients who receive hormone therapy plus radiation therapy to the whole pelvis

  • Description Phase III randomized study using androgen deviation with high dose radiotherapy with or without whole-pelvic radiotherapy

    Key Eligibility
  • Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma, with moderate to high risk for recurrence
  • Clinically negative lymph nodes by imaging, no evidence of bone metastases
  • Zubrod Performance Status 0-1,
  • Exclusion: Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years
  • Prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy
  • Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Prior hormonal therapy, previous or concurrent chemotherapy for prostate cancer
  • Patients status post a negative lymph node dissection are not eligible
  • Unstable angina and or CHF requiring hospitalization within the past 6 months not eligible
  • HIV or immuno-compromised patients are not eligible
  • Patients who are sexually active and not willing/able to use medically acceptable forms of contraception.

  • Applicable Disease Sites Prostate

    Status Open

    Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Swedish American Hospital, Rockford ; UW Hospital and Clinics