Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • CyberKnife radiosurgery

Recruiting Locations

Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Robyn A Cyr
202-444-3068
Robyn.A.Cyr@gunet.georgetown.edu

More Details

Status
Recruiting
Sponsor
Georgetown University

Study Contact

Malika T Danner
202-444-3068
mtd@georgetown.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.