Prostate Cancer Clinical Trial
Official title:
Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
The purpose of this trial is to evaluate a short course of very focused (stereotactic)
external beam radiation therapy for the treatment of early stage prostate cancer.
The investigators will gather scientific information about the tolerance and side effects
this type of radiation. The investigators will then compare these results with those of
standard 8 week course of external beam radiation therapy to see if this study treatment is
equally or more effective in treating prostate cancer.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - Gleason score = 6 and low volume Gleason 7 (3+4) - PSA < 10 - Clinical Stage of T2a or less - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Prior radiation treatment for prostate cancer - Gleason score > 7 - PSA > 10 - Clinical Stage of T2b or greater |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | San Diego Radiosurgery at Palomar Medical Center | Escondido | California |
Lead Sponsor | Collaborator |
---|---|
San Diego Radiosurgery |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PSA decline measured through laboratory testing. | One month following radiosurgery through 5 year follow up | No | |
Secondary | Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit. | One month following radiosurgery through 5 years follow up. | No |
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