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Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059513
Recruitment Status : Recruiting
First Posted : February 1, 2010
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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
Prostate Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Other
Official Title: Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
Actual Study Start Date : January 26, 2010
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To quantify patient quality of life after prostate SBRT using validated questionnaire tools [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059513


Contacts
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Contact: Christopher King, MD 310-825-9771

Locations
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United States, California
UCLA Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Christopher King, MD    310-825-9771      
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Christopher King, MD University of California, Los Angeles
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01059513    
Other Study ID Numbers: 09-10-081
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Keywords provided by Jonsson Comprehensive Cancer Center:
T1c
T2a
T2b
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases