Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

NCT ID: NCT01059513

Last Updated: 2020-11-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-26

Study Completion Date

2020-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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T1c T2a T2b

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher King, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-001787

Identifier Type: -

Identifier Source: org_study_id