Clinical Trials /

Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

NCT01059513

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Withdrawn

Trial Eligibility

Document

Title

  • Brief Title: Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
  • Official Title: Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 09-10-081
  • NCT ID: NCT01059513

Conditions

  • Prostate Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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

Primary Outcome Measures

Measure:To quantify patient quality of life after prostate SBRT using validated questionnaire tools
Time Frame:5 years
Safety Issue:
Description:

Details

Phase:
Primary Purpose:Observational
Overall Status:Recruiting
Lead Sponsor:Jonsson Comprehensive Cancer Center

Trial Keywords

  • T1c
  • T2a
  • T2b

Last Updated

May 3, 2019