Prostate Cancer
Conditions
Keywords
Prostate Cancer, Cancer of the Prostate, Prostate Tumor, Novalis Tx, Novalis, Stereotactic Radiosurgery, Radiosurgery, Radiation
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.
Interventions
RADIATIONStereotactic Radiosurgery using the Novalis Tx
Five treatments given every other day.
Sponsors
San Diego Radiosurgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA decline measured through laboratory testing. | One month following radiosurgery through 5 year follow up |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactJennifer Joiner
Backup ContactJeremy Legg
Outcome results
None listed