A phase II randomized trial of moderate versus ultra-hypofractionated post-prostatectomy radiation therapy

Eligibility: Inclusion Criteria
  •   Men age >= 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA >= 0.1 ng/mL
  •   Interval between prostatectomy and planned radiation therapy start date >= 6 months
  •   KPS >= 70
  •   Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are = 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy)
  •   Ability to complete the EPIC-26 quality of life questionnaire
  •   Ability to obtain paraffin-embedded tissue block from radical prostatectomy specimens
  •   Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
  •   Prior history of pelvic radiation therapy
  •   History of moderate/severe or active Crohn's disease or ulcerative colitis
  •   History of bladder neck or urethral stricture
  •   Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels
  •   Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy
  •   History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer
  •   Any condition that in the opinion of the investigator would preclude participation in this study