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Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer


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.

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Christopher King, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Institutional Review Board

Study ID:

09-10-081

NCT ID:

NCT01059513

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • T1c
  • T2a
  • T2b
  • Prostatic Neoplasms

Name

Location

UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California  90095