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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737151
First Posted: November 29, 2012
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  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
Prostate Adenocarcinoma Stage I Prostate Cancer Radiation: stereotactic body radiation therapy Radiation: four fraction split-course SBRT

Study Type: Interventional
Study Design: 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

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 ]
    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 ]
  • Protocol completion rate [ Time Frame: 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.

  • Patient-reported outcomes [ Time Frame: 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

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

Enrollment: 19
Study Start Date: March 8, 2013
Estimated Study Completion Date: October 31, 2017
Estimated Primary Completion Date: October 31, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737151


Locations
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
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
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01737151     History of Changes
Other Study ID Numbers: MCC-14712
NCI-2012-02545 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 26, 2012
First Posted: November 29, 2012
Last Update Posted: September 15, 2017
Last Verified: September 2017

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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type


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