Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer
The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time.
Conditions:
🦠 Prostate Cancer
🗓️ Study Start (Actual) June 2012
🗓️ Primary Completion (Estimated) June 2028
✅ Study Completion (Estimated) June 2029
👥 Enrollment (Estimated) 167
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Fountain Valley, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Histologically proven prostate adenocarcinoma
    • 2. Biopsy within 12 months of date of registration
    • 3. Clinical Stage I-IV, MX-M0 (AJCC 6th Edition) M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients.
    • 4. Prostate volume: ≤ 100 cc (recommended not required) Determined using: volume = π/6 x length x height x width Measurement from CT or ultrasound ≤90 days prior to registration.
    • 5. ECOG performance status 0-1
    • 6. No prior prostatectomy or cryotherapy of the prostate
    • 7. No prior radiotherapy to the prostate or lower pelvis
    • 8. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
    • 9. Completion of patient questionnaires
    • 10. Consent signed
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 December 2012
  • First Submitted that Met QC Criteria 13 December 2013
  • First Posted 19 December 2013

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 April 2024
  • Last Update Posted 22 April 2024
  • Last Verified April 2024