Clinical Trials /

Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

NCT02334579

Description:

The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer
  • Official Title: Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: IR 5642
  • NCT ID: NCT02334579

Conditions

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

Purpose

The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

Trial Arms

NameTypeDescriptionInterventions
CyberKnife Stereotactic RadiosurgeryExperimentalThis treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically proven prostate adenocarcinoma
    
              -  Clinical stage T1a-T3, N0-Nx, M0-Mx
    
              -  Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a,
                 Gleason 2-6, PSA<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA<20,
                 Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & <20, Nx-0, Mx-0, or CS T1a-T2b,
                 Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or
                 CS T1-3, Gleason ≥8 and/or PSA≥20
    
              -  Karnofsky performance status 70-100
    
              -  Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin),
                 antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide,
                 nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
    
              -  Low and Intermediate risk groups: no hormone ablation for two months prior to
                 enrollment, or during treatment
    
              -  High risk group: three hormone therapy regimens are allowed
    
              -  5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed
    
            Exclusion Criteria:
    
              -  Prior prostatectomy or cryotherapy of the prostate
    
              -  Prior high-dose radiotherapy to the prostate or lower pelvis
    
              -  Implanted hardware or other material that would prohibit appropriate treatment
                 planning or treatment delivery, in the investigator's opinion
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
    Time Frame:8 years
    Safety Issue:
    Description:In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.

    Secondary Outcome Measures

    Measure:Rates of toxicities related to treatment
    Time Frame:5 years
    Safety Issue:
    Description:After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.
    Measure:Disease free survival
    Time Frame:5 years
    Safety Issue:
    Description:Measure disease free survival after five years following cyberknife stereotactic radiosurgery.
    Measure:Overall survival
    Time Frame:5 years
    Safety Issue:
    Description:Measure overall survival after five years following cyberknife stereotactic radiosurgery.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Swedish Medical Center

    Trial Keywords

    • Radiation
    • Stereotactic Radiosurgery
    • Radiotherapy
    • Prostate Tumor
    • Prostate Surgery
    • CyberKnife

    Last Updated

    July 11, 2019