Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery (PR-PROS)
|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: NCT01766492|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2013
Last Update Posted : January 27, 2017
|Condition or disease||Intervention/treatment|
|Prostate Cancer Localized Malignant Neoplasm||Radiation: Stereotactic Body Radiation Therapy (SBRT)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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)
Stereotactic body radiation therapy for prostate
Other Name: CyberKnife radiosurgery
- fatigue [ Time Frame: 2 years ]Use questionnaire to assess patient's symptoms regarding fatigue
- urinary symptoms [ Time Frame: 24 months ]Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
- bowel symptoms [ Time Frame: 24 months ]Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
- sexual function [ Time Frame: 24 months ]Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
- cancer control [ Time Frame: 24 months ]clinical evidence of localized and distal cancer controls
- toxicity [ Time Frame: 24 months ]Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire
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): NCT01766492
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Sean P Collins, MD, PhD||Georgetown University Hospital|