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Study ID CASE1812
Investigator
Kevin Stephans,   Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Title High-Dose Stereotactic Radiation for Prostate Cancer
Conditions Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions Radiation: stereotactic body radiation therapy
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
Phase N/A
Purpose This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • 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 National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (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
  • Performance status - Karnofsky performance status (PS) >= 70
  • Life expectancy of > 5 years, in the opinion of and as documented by the investigator
  • Absolute neutrophil count >= 1.5 k/uL
  • Platelet count >= 100 k/uL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x institutional upper limit of normal
  • Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  • Serum creatinine < 3.0 mg/dL
  • Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR < 2.0).
  • Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to enrollment
  • 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
Exclusion Criteria:
  • Prior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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 situations 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
  • Contraindications to placement of fiducials required for high-precision image guidance (e.g. bleeding disorders which may cause excessive bleeding with placement, requirement for coumadin, international normalized ratio [INR] > 2.0)
  • Patients unable to maintain a full bladder during treatment
  • Previous prostatectomy
  • Inflammatory bowel disease
  • AUA score > 15 in spite of optimal therapy
Study Location N/A
Contact Kevin L. Stephans
216-445-8285
stephak@ccf.org
Information obtained from ClinicalTrials.gov, on 5/24/2013. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664130


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