Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
This study is currently recruiting participants.
Verified March 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Jonsson Comprehensive Cancer Center
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01059513
First received: January 29, 2010
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
This is a single arm clinical program designed to establish and quantify the rates of long-term toxicities and tumor control of a hypo-fractionated course of radiotherapy for the treatment of low-risk localized prostate cancer. Hypo-fractionated radiotherapy is an accelerated radiotherapy course where fewer but larger daily doses of radiotherapy are given. When an image-guided conformal radiotherapy technique is used to deliver hypo-fractionated radiotherapy it is often also called stereotactic body radiotherapy (SBRT).
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: Hypo-fractionated radiotherapy |
Phase 2 |
| 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) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
treatment
Treatment course consists of 5 doses 725cGy, delivered every other day.
|
Radiation: Hypo-fractionated radiotherapy
Treatment course consists of 5 doses 725cGy, delivered every other day.
Other Name: stereotactic body radiotherapy (SBRT)
|
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
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: | March 4, 2013 |
| 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 June 17, 2013