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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01766492
Other study ID # 2012-1175
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2012
Est. completion date April 2022

Study information

Verified date March 2021
Source Georgetown University
Contact Malika T Danner
Phone 202-444-3068
Email mtd@georgetown.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility 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


Intervention

Radiation:
Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy for prostate

Locations

Country Name City State
United States Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary fatigue Use questionnaire to assess patient's symptoms regarding fatigue 2 years
Primary urinary symptoms Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery 24 months
Primary bowel symptoms Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery 24 months
Primary sexual function Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery 24 months
Secondary cancer control clinical evidence of localized and distal cancer controls 24 months
Secondary toxicity symptoms Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire 24 months
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