Clinical Trials /

CyberKnife Dose Escalation Prostate Cancer Trial

NCT03822494

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: CyberKnife Dose Escalation Prostate Cancer Trial
  • Official Title: CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: PCK-02
  • NCT ID: NCT03822494

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Neoplasm

Purpose

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.

Detailed Description

      The optimal radiation schedule for the curative treatment of prostate cancer remains unknown.
      Prostate cancer patients receiving radiation therapy are typically treated 5 days per week
      for 8-9 weeks. Recent data suggest that large radiation fraction sizes are radio-biologically
      favorable over lower fraction sizes in prostate cancer radiotherapy. The sensitivity of a
      tumor or normal tissue to fraction size of radiation can be approximated by the alpha-beta
      ratio. It has been suggested that the alpha/beta ratio for prostate cancer is actually as low
      as 1.5 implying that the current radiation therapy paradigm for prostate cancer treatment
      might be fundamentally flawed, as high fraction sizes would be expected to damage tumor more
      readily.

      Typical prostate SBRT doses do not appear to have similar efficacy in higher risk prostate
      cancer suggesting even higher doses are required. Many techniques including dose escalated
      external beam radiation therapy (EBRT), proton therapy (PT) and brachytherapy have been
      employed to increase dose to the prostate. Data from the ASCEND-RT trial utilizing low dose
      rate brachytherapy boost showed a dramatic 21% improvement in biochemical control at 9 years
      favoring brachytherapy boost compared to conventional dose escalated EBRT radiation therapy.
      However, no corresponding benefit was identified in overall survival, incidence of bone
      metastases or prostate cancer specific mortality while a 3 fold increase in late urinary
      toxicity was noted.

      SBRT is well tolerated with minimal acute and late side effects. In this protocol, CK-SBRT
      will be used to target the microscopic and gross disease in the prostate, seminal vesicles.
      An escalated dose of 40 Gy in 5 fractions will be delivered to the entire target volume while
      any nodules visible within the prostate gland on endorectal MRI will receive 50 Gy in 5
      fractions.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalated CyberKnife SBRTExperimental

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0
    Time Frame:24 Months
    Safety Issue:
    Description:Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using

    Secondary Outcome Measures

    Measure:Biochemical Disease Free Survival
    Time Frame:24 Months
    Safety Issue:
    Description:Time in months from completion of SBRT to biochemical failure
    Measure:Duration of local control
    Time Frame:24 Months
    Safety Issue:
    Description:time in months from SBRT completion to local failure
    Measure:Distant Failure
    Time Frame:24 Months
    Safety Issue:
    Description:time in months from SBRT completion to distant failure
    Measure:Disease Free Survival
    Time Frame:24 Months
    Safety Issue:
    Description:time in months from the date that the patient is determined to be free of disease to the date of known disease recurrence for any measure of disease.
    Measure:Disease Specific Survival
    Time Frame:24 Months
    Safety Issue:
    Description:time in months from completion of SBRT to death due to prostate cancer, other causes with active malignancy, or complications from treatment.
    Measure:Overall Survival
    Time Frame:5 years
    Safety Issue:
    Description:ime in months from SBRT completion until death

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Crozer-Keystone Health System

    Trial Keywords

    • radiation therapy
    • Cyberknife
    • SBRT
    • Protons

    Last Updated

    November 13, 2019