Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery (PR-PROS)

Georgetown University

Status: Enrolling

Conditions: Localized Malignant Neoplasm; Prostate Cancer

Treatments: Radiation: Stereotactic Body Radiation Therapy (SBRT)

Study type: Observational

Funder types: Other

Identifiers

NCT01766492

2012-1175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

male (age > 18 y/o) with prostate cancer

Description:

Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer

Treatment:

Radiation: Stereotactic Body Radiation Therapy (SBRT)