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CyberKnife Dose Escalation Prostate Cancer Trial
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate cancer. Multiple single institution experiences suggest high biochemical control rates with acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate radiation dose delivery to the prostate while sparing normal tissue.
Conditions:
🦠 Prostate Cancer 🦠 Prostate Adenocarcinoma 🦠 Prostate Neoplasm
🗓️ Study Start (Actual) 12 July 2018
🗓️ Primary Completion (Estimated) 12 July 2023
✅ Study Completion (Estimated) 12 July 2028
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Havertown, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Histologically confirmed adenocarcinoma of the prostate diagnosed within 360 days of enrollment.
    • * Prostate Specific Antigen (PSA) documented within 90 days prior to registration.
    • * Clinical staging completed within 90 days of registration.
    • * No Nodal or Distant Metastases documented on CT or MRI of the pelvis and bone scan.
    • * Unfavorable Risk Prostate Carcinoma as Described is documented.
    • * No prior pelvic radiotherapy.
    • * No prior Trans-urethral resection of the prostate (TURP).
    • * Prostate volume \< 100 cc
    • * American Urologic Association (AUA) score \< 20
    • * No recent (within 5 years) or concurrent cancers other than non-melanoma skin cancers.
    • * Patient must have no medical or psychiatric illnesses that would interfere with treatment or follow-up.
    • * No implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and treatment delivery is allowed.
    • * Candidate for rectal spacer placement

    Exclusion Criteria:

    • * Other cancer diagnosis other than non-melanoma skin cancer with 5 years
    • * Prostate size greater than 100cc
    • * AUA greater than 20
    • * Implanted hardware impacting imaging
    • * Metastatic prostate cancer
    • * Contraindication to hormone therapy
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 28 January 2019
  • First Submitted that Met QC Criteria 28 January 2019
  • First Posted 30 January 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 April 2021
  • Last Update Posted 21 April 2021
  • Last Verified April 2021
I'm interested ...!!