Clinical Trials /

Safety and Efficacy of 23 Gy for High Dose Rate (HDR) Prostate Brachytherapy

NCT03424850

Description:

The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of 23 Gy for High Dose Rate (HDR) Prostate Brachytherapy
  • Official Title: A Phase I/II Study Evaluating the Safety and Efficacy of 23 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Clinical Trial IDs

  • ORG STUDY ID: 201801118
  • NCT ID: NCT03424850

Conditions

  • Prostate Cancer
  • Prostate Neoplasm

Purpose

The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.

Trial Arms

NameTypeDescriptionInterventions
HDR brachytherapyExperimental-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
    
              -  Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable
                 intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no
                 more than one NCCN intermediate risk factor).
    
              -  Prior androgen deprivation therapy is allowed and may have been initiated up to 6
                 months prior to the date of the HDR implant. The complete duration of androgen
                 deprivation therapy can range from 4 months to 36 months provided it has been
                 initiated no more than 6 months prior to the date of the HDR implant.
    
              -  At least 18 years of age.
    
              -  ECOG performance status ≤ 2
    
              -  Able to understand and willing to sign an IRB approved written informed consent
                 document (or that of legally authorized representative, if applicable).
    
            Exclusion Criteria:
    
              -  Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
    
              -  A history of other malignancy ≤ 5 years previous with the exception of basal cell or
                 squamous cell carcinoma of the skin which were treated with local resection only.
    
              -  Currently receiving any other investigational agents.
    
              -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
                 infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
                 arrhythmia.
    
              -  Unable to undergo general, spinal or local anesthesia.
    
              -  Prior TURP
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Biochemical control experienced by patients with prostate cancer treated with an HDR implant
    Time Frame:Through 3 years after implant
    Safety Issue:
    Description:-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir

    Secondary Outcome Measures

    Measure:Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant
    Time Frame:Through 3 years after implant
    Safety Issue:
    Description:-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
    Measure:Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant
    Time Frame:Through 3 years after implant
    Safety Issue:
    Description:-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Washington University School of Medicine

    Last Updated

    November 7, 2019