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Protocol No. UW14083

Principal Investigator Morris, Zachary

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Normal Structure-Sparing IMRT Planning

Objective The purpose of this study is to evaluate the Stereotactic Body Radiotherapy (SBRT) method of delivering high dose radiation to the prostate in five treatments using advanced radiation delivery techniques. SBRT allows us to increase the radiation dose to the tumor and lower the radiation dose to normal tissue.

Treatment For prostate cancer, SBRT consists of 5 treatments over 1.5 weeks. This method of delivering radiation in five treatments has been studied previously and is considered a promising treatment approach. This treatment schedule gives a higher dose of radiation per treatment over a shorter overall treatment period in comparison to standard radiation treatment.

Description In this study, we will either deliver a conventional prostate SBRT radiation dose, which is 7.5 Gray per treatment, or, if special imaging (a magnetic resonance imaging scan (MRI) of the prostate permits, will offer you treatment to a higher dose of 8 Gy per treatment. If this imaging identifies a large enough tumor within the prostate, we will "boost" that tumor to an even stronger dose of 9 Gray per treatment while leaving the rest of the prostate at the lower 8 Gray dose. The purpose of this "boost" dose is to deliver the highest radiation doses to the areas of the prostate that contain the most tumor.

Key Eligibility
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 365 days of study enrollment
  • History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment
  • Gleason score ≤ 7, no tertiary pattern >5
  • Most recent PSA within 60 days of enrollment
  • Maximum PSA ≤ 20 ng/ml (not within 20 days after biopsy)
  • Up to a total of 1 year of androgen deprivation allowed
  • Confirmation that insurance will cover SBRT through normal hospital authorization process
  • Clinical Stage ≤ T2b and no radiographic evidence of T4 disease
  • Clinical Stage N0, M0
  • Patients with prosthetic implants in the pelvic region that contain metal materials will be excluded
  • Patients excluded if ≤ 3 months from a TURP procedure
  • Patients excluded if they have significant urinary obstruction in spite of alpha blocker use
  • Patients excluded if they have had previous pelvic irradiation, prostate brachytherapy
  • Patients excluded if they have had previous radical (prostatectomy) or cryosurgery for prostate cancer
  • Patients excluded if the have active bacterial or fungal infection requiring intravenous antibiotics at the time of registration, active Crohn's Disease or ulcerative colitis, or scleroderma

Applicable Disease Sites Prostate

Therapies Involved Radiotherapy

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics