Objectives: This randomized phase III trial has three arms. The control group receives prostate bed radiotherapy (PBRT) alone after surgery. In one experimental arm, men receive PBRT, short-term androgen-deprivation therapy, and pelvic lymph node radiation therapy; in another they are given PBRT and short-term androgen-deprivation therapy without pelvic lymph node radiation therapy. Freedom from disease progression is the primary outcome measure.
Key entry or exclusion criteria: Lymph node dissection is not required but patients known to have positive nodes are not eligible.
Locations: 438 sites.
Goal: 1,764 patients.
Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT00567580
NIH clinical trials identifier: NCT00567580