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Title   A phase I dose escalation study using ultra-hypofractionated, image-guided, intensity-modulated radiotherapy in prostate cancer
Full Title   A phase I dose escalation study using ultra-hypofractionated, image-guided, intensity-modulated radiotherapy in prostate cancer
Disease/Condition   Prostate Cancer
Description   This study aims to assess the toxicity of definitive hypofractionated external beam radiation therapy in patients with low and intermediate risk prostate cancer.
Eligibility Criteria   Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
• Age > 18
• KPS > 70
• Pre-treatment endorectal coil MRI at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
• Prostate size < 60 cc
• Whole body bone scan negative for metastatic disease
• International Prostate Symptom Score < 15
Exclusion Criteria   • Prior androgen deprivation therapy
• Elective pelvic lymph node irradiation
• KPS < 70
• Endorectal coil MRI evidence of radiographic T3, T4 or N1 disease
• Presence of distant metastasis
• 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:
o Platelet count less than 75,000/ml
o Hb level less than 10 gm/dl
o WBC less than 3.5/ml

• Abnormal renal function tests (creatinine > 1.5)
Principal Investigator   Madhur Garg, MD
Contact Name   Hilda Haynes-Lewis, NP
Phone   (718) 920-8819
Contact Email   Hilda Haynes-Lewis, NP
Post Date   12/08/2011
Protocol Number   11-06-232
Inclusion/Notes   radiation therapy trial
Status   Active
Adult Clinical Trial   No
Pediatric Clinical Trial   No