Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Jonsson Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01059513
First received: January 29, 2010
Last updated: February 4, 2014
Last verified: January 2014
  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.


Condition
Prostate Cancer

Study Type: Observational
Official Title: Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • To quantify patient quality of life after prostate SBRT using validated questionnaire tools [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059513

Contacts
Contact: Christopher King, MD 310-825-9771

Locations
United States, California
UCLA Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Christopher King, MD    310-825-9771      
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Christopher King, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01059513     History of Changes
Other Study ID Numbers: 09-10-081
Study First Received: January 29, 2010
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
T1c
T2a
T2b

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 26, 2014