Clinical trial · Observational
Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
NCT01059513CI-TRIAL-00048503completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To quantify patient quality of life after prostate SBRT using validated questionnaire tools
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.