Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059513
• Other study ID #: 10-001787
• Status: Completed
• Start date: January 26, 2010
• Est. completion date: March 19, 2020

Study information

• Verified date: May 2020
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	UCLA Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify patient quality of life after prostate SBRT using validated questionnaire tools		5 years