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

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

The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.

Inclusion Criteria:

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

Exclusion Criteria:

• 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)