Stereotactic Body Radiotherapy for Prostate Cancer
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer|
- Biochemical control rate [ Time Frame: one year ] [ Designated as safety issue: No ]Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals.The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used.
- late toxicity rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]Toxicity will be recorded using the CTCAE grading criteria.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Radiation: stereotactic body radiotherapy
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
|Contact: Jaymeson Stroud, MDfirstname.lastname@example.org|
|United States, Missouri|
|Mercy Hospital St. Louis||Recruiting|
|St. Louis, Missouri, United States, 63141|