Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT01737151|
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma Stage I Prostate Cancer||Radiation: stereotactic body radiation therapy Radiation: four fraction split-course SBRT||Not Applicable|
I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||March 8, 2013|
|Actual Primary Completion Date :||November 9, 2017|
|Estimated Study Completion Date :||November 9, 2018|
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
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
- 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
- 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 ]
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
|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|
|Principal Investigator:||Timothy J Harris, M.D.||Massey Cancer Center|