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.
Completed
| Name | Type | Description | Interventions |
|---|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | To quantify patient quality of life after prostate SBRT using validated questionnaire tools |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: |
| Phase: | |
| Primary Purpose: | Observational |
| Overall Status: | Completed |
| Lead Sponsor: | Jonsson Comprehensive Cancer Center |
November 25, 2020
