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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

To quantify patient quality of life after prostate SBRT using validated questionnaire tools

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2020
Study completion: 2020
First posted: Feb 1, 2010
Registry last updated: Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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