Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
NCT ID: NCT01766492
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2012-12-31
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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male (age > 18 y/o) with prostate cancer
Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer
Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy for prostate
Interventions
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Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy for prostate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed study-specific consent
* Prostate Specific Antigen (PSA) within 60 days of registration
Exclusion Criteria
* 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
18 Years
99 Years
MALE
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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Principal Investigators
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Sean P Collins, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University Hospital
Locations
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Georgetown University Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1016/S1470-2045(07)70143-2.
Dess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31.
Other Identifiers
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2012-1175
Identifier Type: -
Identifier Source: org_study_id
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