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Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

This study is currently recruiting participants.
Verified August 2016 by Jonsson Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059513
First Posted: February 1, 2010
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  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
Study Design: Observational Model: Other
Time Perspective: Other
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 ]

Estimated Enrollment: 60
Study Start Date: January 20, 2010
Estimated Study Completion Date: January 31, 2019
Estimated Primary Completion Date: January 31, 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01059513     History of Changes
Other Study ID Numbers: 09-10-081
First Submitted: January 29, 2010
First Posted: February 1, 2010
Last Update Posted: April 21, 2017
Last Verified: August 2016

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