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

Recruiting

• Conditions: Prostate Cancer; Localized Malignant Neoplasm
• Interventions: Radiation: Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT01766492
• Lead Sponsor: Georgetown University

Brief 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.

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
male (age > 18 y/o) with prostate cancer	Stereotactic Body Radiation Therapy (SBRT)	Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer

Primary Outcome Measures

Name	Time	Method
bowel symptoms	24 months	Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
fatigue	2 years	Use questionnaire to assess patient's symptoms regarding fatigue
urinary symptoms	24 months	Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
sexual function	24 months	Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery

Secondary Outcome Measures

Name	Time	Method
toxicity symptoms	24 months	Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire
cancer control	24 months	clinical evidence of localized and distal cancer controls

Trial Locations

Locations (1)

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States