Prostate Cancer Clinical Trial

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

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.

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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.

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Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

200

Study ID:

NCT01766492

Recruitment Status:

Recruiting

Sponsor:

Georgetown University

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There is 1 Location for this study

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Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
Robyn A Cyr
Contact
202-444-3068
[email protected]
Sean P Collins, MD, PhD
Contact
202-444-3292
[email protected]
Sean P Collins, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

200

Study ID:

NCT01766492

Recruitment Status:

Recruiting

Sponsor:


Georgetown University

How clear is this clinincal trial information?

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