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

Primary Purpose

Prostate Adenocarcinoma, Stage I Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stereotactic body radiation therapy
four fraction split-course SBRT
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Medical Center
  • Hunter Holmes McGuire VA Medical Center
  • Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard stereotactic body radiation therapy (SBRT)

Arm II (four fraction split-course SBRT)

Arm Description

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

Patients undergo 2 fractions of SBRT in weeks 1 and 4

Outcomes

Primary Outcome Measures

Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Will be tested using a continuity corrected chi-square test

Secondary Outcome Measures

Biochemical failure as defined by the Phoenix definition
Protocol completion rate
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.
Patient-reported outcomes
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
Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria

Full Information

First Posted
November 26, 2012
Last Updated
August 29, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT01737151
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
March 8, 2013 (undefined)
Primary Completion Date
November 9, 2017 (Actual)
Study Completion Date
November 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule. SECONDARY OBJECTIVES: I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule. II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria). III. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Stage I Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard stereotactic body radiation therapy (SBRT)
Arm Type
Active Comparator
Arm Description
Patients undergo standard daily fractions of SBRT over 7-8.5 weeks
Arm Title
Arm II (four fraction split-course SBRT)
Arm Type
Experimental
Arm Description
Patients undergo 2 fractions of SBRT in weeks 1 and 4
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy
Other Intervention Name(s)
SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Intervention Description
Undergo SBRT
Intervention Type
Radiation
Intervention Name(s)
four fraction split-course SBRT
Intervention Description
four fraction split-course SBRT
Primary Outcome Measure Information:
Title
Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Description
Will be tested using a continuity corrected chi-square test
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Biochemical failure as defined by the Phoenix definition
Time Frame
Up to 5 years
Title
Protocol completion rate
Description
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.
Time Frame
Up to 5 years
Title
Patient-reported outcomes
Description
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
Time Frame
Up to 5 years
Title
Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Harris, M.D.
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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

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