Prostate Cancer (RTOG 0924): Androgen Deprivation and High dose Radiation Therapy With or Without Whole Pelvic Radiation
A Phase III Randomized Trial of Androgen Deprivation Therapy and High Dose Radiation Therapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer.
Risk determined by the following combinations, must meet one of the three following combinations --
* Gleason 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml; * Gleason 6 + T2c-T4 or > 50% (positive) biopsies + PSA < 50 ng/ml;
* Gleason 6 + T1c-T2b (palpation) + PSA > 20 ng/ml.
Clinically negative lymph nodes as established by imaging w/in 90 days prior to registraiton.
No evidence of bone metastasis on bone scan w/in 120 day of registration.
Zubrod Performance Status = 0-1
Exclusion Criteria Includes (not a complete list): ~Prior invasive malignancy unless disease free for minimum 3 yrs; ~previous prostate surgery, pelvic/prostate radiation or hormone therapy; ~Prior finasteride, dutasteride or dutasteride/tamsulosin use within 30 - 90 days; ~previous or concurrent chemo for prostate cancer; ~No severe, active co-morbidities as defined per protocol