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Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01059513
Collaborator
(none)
167
Enrollment
1
Location
121.7
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    167 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
    Actual Study Start Date :
    Jan 26, 2010
    Actual Primary Completion Date :
    Mar 19, 2020
    Actual Study Completion Date :
    Mar 19, 2020

    Outcome Measures

    Primary Outcome Measures

    1. To quantify patient quality of life after prostate SBRT using validated questionnaire tools [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).

    • The ability to understand and willingness to sign a written informed consent are necessary.

    Exclusion Criteria:

    • Patients with tumor parameters that fall outside of the inclusion criteria.

    • Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.

    • Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).

    • A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.

    • The use of other concurrent investigational agents.

    • There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.

    • No life expectancy restrictions will apply.

    • Performance status will not be considered.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Christopher King, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01059513
    Other Study ID Numbers:
    • 10-001787
    First Posted:
    Feb 1, 2010
    Last Update Posted:
    Nov 25, 2020
    Last Verified:
    May 1, 2020
    Keywords provided by Jonsson Comprehensive Cancer Center
    T1c
    T2a
    T2b
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Nov 25, 2020