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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01737151
First received: November 26, 2012
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Prostate Adenocarcinoma
Stage I Prostate Cancer
Radiation: stereotactic body radiation therapy
Radiation: four fraction split-course SBRT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Will be tested using a continuity corrected chi-square test


Secondary Outcome Measures:
  • Biochemical failure as defined by the Phoenix definition [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Protocol completion rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

    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


Other Outcome Measures:
  • Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737151

Contacts
Contact: Mitchell Anscher, MD 804-828-7238 manscher@mcvh.vcu.edu
Contact: Diane Holdford, RN 804-828-0296 daholdfo@vcu.edu

Locations
United States, Virginia
University of Virginia Medical Center Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Timothy N Showalter, MD    434-243-1462    tns3b@virginia.edu   
Principal Investigator: Timothy N Showalter, MD         
Virginia Commonwealth University, Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Mitchell Anscher, MD    804-828-7238    manscher@mcvh-vcu.edu   
Contact: Diane Holdford, RN    804-828-0296    daholdfo@vcu.edu   
Principal Investigator: Mitchell Anscher, MD         
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Vicki Skinner, RN    804-675-5646    vicki.skinner@va.gov   
Principal Investigator: Michael Chang, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Mitchell Anscher, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01737151     History of Changes
Other Study ID Numbers: MCC-14712, NCI-2012-02545
Study First Received: November 26, 2012
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 18, 2014