Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01059513 |
Recruitment Status :
Completed
First Posted : February 1, 2010
Last Update Posted : November 25, 2020
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Condition or disease |
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Prostate Cancer |
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 : | January 26, 2010 |
Actual Primary Completion Date : | March 19, 2020 |
Actual Study Completion Date : | March 19, 2020 |

- To quantify patient quality of life after prostate SBRT using validated questionnaire tools [ Time Frame: 5 years ]

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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 |
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.

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
United States, California | |
UCLA Jonsson Comprehensive Cancer Center | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Christopher King, MD | University of California, Los Angeles |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01059513 |
Other Study ID Numbers: |
10-001787 |
First Posted: | February 1, 2010 Key Record Dates |
Last Update Posted: | November 25, 2020 |
Last Verified: | May 2020 |
T1c T2a T2b |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |