Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
Status
RECRUITING
Phase
Age
18 - 99 Years
Enrollments
200Conditions
Prostate Cancer, Localized Malignant NeoplasmSummary
Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.
Detailed Description
Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):
The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.
Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.
Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.
Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Robyn A Cyr
- 202-444-3068
- [email protected]
Principal Investigator
- Sean P Collins, MD, PhD
Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of prostate
* Signed study-specific consent
* Prostate Specific Antigen (PSA) within 60 days of registration
Exclusion Criteria:
* Prior pelvic radiotherapy
* Prior radical prostate surgery
* Medical or psychiatric illness that would interfere with treatment or follow up
* Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
Study Plan
male (age > 18 y/o) with prostate cancer
Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer
RADIATION:
Stereotactic Body Radiation Therapy (SBRT)Description:
Stereotactic body radiation therapy for prostate
Outcome Measures
Primary Outcome Measures
fatigue
urinary symptoms
bowel symptoms
sexual function
Secondary Outcome Measures
cancer control
toxicity symptoms
Timeline
Last Updated
February 23, 2023Start Date
January 11, 2013Today
February 5, 2025Completion Date ( Estimated )
April 1, 2025
Sponsors of this trial
Lead Sponsor
Georgetown University
RECRUITING 
21 - 64 Years