Clinical Trials /

CyberKnife Radiosurgery for Localized Prostatic Carcinoma

NCT01045148

Description:

Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CyberKnife Radiosurgery for Localized Prostatic Carcinoma
  • Official Title: Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study

Clinical Trial IDs

  • ORG STUDY ID: Virtual HDR CK Radiosurgery
  • NCT ID: NCT01045148

Conditions

  • Prostate Cancer

Purpose

Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Detailed Description

      Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a
      tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate
      brachytherapy is a particularly elegant brachytherapy dose sculpting method that is
      effectively used in the curative treatment of prostate cancer; however, it requires hospital
      admission and many temporarily implanted transperineal catheters to deliver the radiation
      source to the target volume, resulting in significant patient discomfort. CyberKnife delivers
      a form of radiation treatment that is so precise, it appears capable of reconstructing HDR
      prostate radiation dose sculpting, without the hospital admission and without the catheters.
      The CyberKnife device is also used for classic radiosurgery, with accuracy comparable to the
      Gamma Knife, but unlike the Gamma Knife, has the capability to target lesions anywhere in the
      body with similar accuracy. The aim of this study is to compare CyberKnife morbidity and
      efficacy with that of HDR and other local treatment methods such a permanent seed prostate
      brachytherapy in the treatment of prostate cancer.
    

Trial Arms

NameTypeDescriptionInterventions
CyberKnife RadiosurgeryOtherCyberKnife Radiosurgery

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b
                 (AJCC 6th Edition, see Appendix II), NX/N0, M0.
    
              -  Karnofsky performance status > 80.
    
              -  Patient must be ≥ 18 years of age.
    
                   -  Gleason Sum < or = 7
    
                   -  Prostate-specific antigen < or = 20 ng/ml
    
              -  Patients must sign a study-specific informed consent form prior to study entry.
    
            Exclusion Criteria:
    
              -  Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
    
              -  Gleason Score > 7.
    
              -  PSA > 20 ng/ml.
    
              -  Lymph node involvement (N1).
    
              -  Evidence of distant metastases (M1).
    
              -  Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical
                 clips or other metallic foreign bodies.
    
              -  History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three
                 months prior to treatment).
    
              -  Previous or concurrent cancers other than basal, in situ, or squamous cell skin
                 cancers unless disease-free for ≥ 5 years.
    
              -  Major medical or psychiatric illness, which in the investigator's opinion, would
                 prevent completion of treatment and would interfere with follow-up.
    
              -  Metallic Hip prosthesis.
    
              -  History of inflammatory bowel disease
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:Accepts Healthy Volunteers

    Primary Outcome Measures

    Measure:To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter.
    Time Frame:5 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:CyberKnife Centers of San Diego

    Trial Keywords

    • Prostatic Cancer
    • Prostatic Neoplasms
    • Prostate Neoplasms
    • Cancer of the Prostate

    Last Updated

    July 18, 2017