Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

Lab values

• Prior androgen deprivation therapy for prostate cancer
  • Elective pelvic lymph node irradiation
  • KPS \< 70
  • Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
  • Presence of distant metastasis as determined by:
  • o alkaline phosphatase \> or = to ULN or
  • whole body bone scan positive for osseous metastases
  • Prior history of transurethral resection of the prostate
  • Prior history of chronic prostatitis
  • Prior history of urethral stricture
  • Prior history of pelvic irradiation
  • History of inflammatory bowel disease
  • Unable to give informed consent
  • Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following
  • Platelet count less than 75,000/ml
  • Hb level less than 10 gm/dl
  • WBC less than 3.5/ml
  • Abnormal renal function tests (creatinine \> 1.5)

• Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.
• Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
• Low risk patients will be defined as:
  • PSA \< or = to 10 ng/ml and
  • Gleason score = 6 and
  • Clinical Stage \< or = to T2a
• Intermediate risk patients will be defined as:
  • PSA 10-20 ng/ml or
  • Gleason score = 7 or
  • Clinical stage T2b/T2c
  • Additionally, patients will be required to meet the following criteria:
• Age \> or = to 18
• KPS \> or = to 70
• Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
• Prostate size \< or = to 60 cc
• International Prostate Symptom Score \< or = to 15