Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01059513

10-001787

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.