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Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Terminated
CT.gov ID
NCT01737151
Collaborator
(none)
19
Enrollment
3
Locations
2
Arms
56.1
Duration (Months)
6.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Condition or Disease Intervention/Treatment Phase
  • Radiation: stereotactic body radiation therapy
  • Radiation: four fraction split-course SBRT
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
SECONDARY OBJECTIVES:

  1. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

  2. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).

  3. To determine the protocol completion rate. IV. To describe patient-reported outcomes using International Index of Erectile Function (IIEF) and EPIC Urinary and Bowel Assessment questionnaires.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
Study Start Date :
Mar 8, 2013
Actual Primary Completion Date :
Nov 9, 2017
Actual Study Completion Date :
Nov 9, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (standard stereotactic body radiation therapy (SBRT)

Patients undergo standard daily fractions of SBRT over 7-8.5 weeks

Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT, stereotactic radiation therapy, stereotactic radiotherapy

    		•
    Experimental: Arm II (four fraction split-course SBRT)

    Patients undergo 2 fractions of SBRT in weeks 1 and 4

    Radiation: four fraction split-course SBRT
    four fraction split-course SBRT

    Outcome Measures

    Primary Outcome Measures

    1. Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria [2 years]

      Will be tested using a continuity corrected chi-square test

    Secondary Outcome Measures

    1. Biochemical failure as defined by the Phoenix definition [Up to 5 years]

    2. Protocol completion rate [Up to 5 years]

      The portion of patients completing the planned protocol with no unacceptable protocol violations is anticipated to be greater than 90%. A completion rate of 70% is deemed unacceptably low.

    3. Patient-reported outcomes [Up to 5 years]

      International Index of Erectile Function (IIEF) and Expanded Prostate Cancer Index Composite urinary Assessment (EPIC) urinary and bowel assessments will be used to collect patient-reported outcomes. IIEF is a widely used instrument for the evaluation of male sexual function. It is has been recommended as tool for clinical trials of erectile dysfunction and for diagnostic evaluation of erectile dysfunction severity. 15 questions 1=very low (worst) to 5=very high (best). The EPIC urinary and bowel assessments are comprehensive instruments designed to evaluate urinary and bowel symptoms, thereby providing a unique tool for assessment of quality of life issues important in prostate cancer management. 9 questions 0=no problem to 5=big problem

    4. Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria [Up to 90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:

    • Low-risk disease - Histopathology score (Gleason sum): =<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: <10

    • Intermediate-risk disease as either:

    • Histopathology score (Gleason sum) =< 6, T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) > 10 but =< 20; or

    • Histopathology score (Gleason sum) 7 with =< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA < 10

    • Charlson index of comorbidity score =< 4

    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease

    • Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment

    • Patients with a history of pelvic irradiation for any reason

    • Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two

    • Prior radiation therapy, brachytherapy, or cryotherapy

    • Prior surgical procedure involving peri-rectal and peri-prostatic area

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia Medical Center Charlottesville Virginia United States 22908
    2 Hunter Holmes McGuire VA Medical Center Richmond Virginia United States 23249
    3 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Timothy J Harris, M.D., Massey Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT01737151
    Other Study ID Numbers:
    • MCC-14712
    • NCI-2012-02545
    First Posted:
    Nov 29, 2012
    Last Update Posted:
    Sep 3, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Adenocarcinoma

    Study Results

    No Results Posted as of Sep 3, 2019