Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To quantify patient quality of life after prostate SBRT using validated questionnaire tools	5 years

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Christopher King, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2010
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: January 29, 2010
• First Posted (Estimate): February 1, 2010

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: T2a; T2b; T1c
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 10-001787