Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2018
Start Date:December 2012
End Date:April 2019
Contact:Malika T Danner
Email:mtd@georgetown.edu
Phone:202-444-3068

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Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)

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.

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.

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
We found this trial at
1
site
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Sean P Collins, MD, PhD
Phone: 202-444-3068
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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