Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
Phase 1
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Stereotactic Radiosurgery using the Novalis Tx
- Registration Number
- NCT00969202
- Lead Sponsor
- San Diego Radiosurgery
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic Radiosurgery using NovalisTx Stereotactic Radiosurgery using the Novalis Tx Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
- Primary Outcome Measures
Name Time Method PSA decline measured through laboratory testing. One month following radiosurgery through 5 year follow up
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
San Diego Radiosurgery at Palomar Medical Center
🇺🇸Escondido, California, United States