Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01059513
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-26
• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-01
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 167

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To quantify patient quality of life after prostate SBRT using validated questionnaire tools	5 years

Trial Locations

Locations (1)

UCLA Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States