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Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)


N/A
18 Years
N/A
Open (Enrolling)
Male
Clinically Localized Prostate Cancer

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Trial Information

Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)


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.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of prostate

- Signed study-specific consent

- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

fatigue

Outcome Description:

Use questionnaire to assess patient's symptoms regarding fatigue

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

2012-1175

NCT ID:

NCT01766492

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Clinically Localized Prostate Cancer
  • prostate cancer
  • CyberKnife
  • Prostatic Neoplasms

Name

Location

Georgetown University HospitalWashington, District of Columbia  20007