Title High-Dose Stereotactic Radiation for Prostate Cancer
IRB CASE 1812
Hospital Fairview, Hillcrest, Independence, Main Campus, Strongsville
- Primary Objective
- To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer. Our hypothesis is that toxicity will not be excessive (defined as greater than 15% for either GI or GU) compared to the historical standard of fractionated IMRT with image-guidance (which results in 5% grade 3 GU and 5% grade 3 GI toxicity).
- Secondary Objective
- follow quality of life after SBRT using EPIC and AUA scores.
- assess biochemical control after high-dose SBRT
- The patient must have prostate adenocarcinoma proven by histologic diagnosis
- The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the NCCN guidelines? Any patient whom is defined as high-risk must undergo screening with CT or MRI of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes. Low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation.
- Age ≥18 years.
- Performance status - Karnofsky PS ≥ 70
- Life expectancy of > 5 years, in the opinion of and as documented by the investigator.
- Patients must have adequate hematologic, hepatic, and renal function as defined below:
- Absoluteneutrophil count≥1.5 k/uL
- Platelet count ≥ 100 k/uL
- Total bilirubin within normal institutional limits
- AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- ALT (SGPT) ≤2.5 X institutional upper limit of normal
- Serum Creatinine <3.0 mg/dL
- Patients must have PSA drawn within the 90 days prior to enrollment.
- The effects of radiation on maturing sperm are unknown. For this reason and beause radiation, as well as other therapeutic agents used in this study, are known to be teratogenic, men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Prior treatment toxicities must be resolved to < Grade 1 according to NCI CTCAE Version 4.0
- Patients who are receiving any other investigational agents.
- Evidence of metastatic disease prior to radiation.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- Prior pelvic radiation therapy.
- Patients whom are planned to receive pelvic nodal radiation are excluded.
- Weight > 350 lbs.
- Patients unable to maintain a full bladder during treatment
- Previous prostatectomy
- Inflammatory bowel disease
- AUA score > 15 in spite of optimal therapy.