Overview

This trial is active, not recruiting.

Conditions prostate cancer, localized malignant neoplasm
Treatment stereotactic body radiation therapy (sbrt)
Sponsor Georgetown University
Start date December 2012
End date December 2016
Trial size 200 participants
Trial identifier NCT01766492, 2012-1175

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer
stereotactic body radiation therapy (sbrt) CyberKnife radiosurgery
Stereotactic body radiation therapy for prostate

Primary Outcomes

Measure
fatigue
time frame: 2 years
urinary symptoms
time frame: 24 months
bowel symptoms
time frame: 24 months
sexual function
time frame: 24 months

Secondary Outcomes

Measure
cancer control
time frame: 24 months
toxicity
time frame: 24 months

Eligibility Criteria

Male participants from 18 years up to 99 years old.

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

Additional Information

Official title Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)
Principal investigator Sean P Collins, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Georgetown University.