Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
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.
|Prostate Cancer||Radiation: Stereotactic Radiosurgery using the Novalis Tx||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage|
- PSA decline measured through laboratory testing. [ Time Frame: One month following radiosurgery through 5 year follow up ]
- Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit. [ Time Frame: One month following radiosurgery through 5 years follow up. ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic Radiosurgery using NovalisTx
Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
Radiation: Stereotactic Radiosurgery using the Novalis Tx
Five treatments given every other day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969202
|Contact: Jennifer Joiner||760-739-3185||Jennifer.firstname.lastname@example.org|
|Contact: Jeremy Legg||615-920-1282||jlegg@Allianceoncology.com|
|United States, California|
|San Diego Radiosurgery at Palomar Medical Center||Recruiting|
|Escondido, California, United States, 92025|
|Contact: Jennifer Joiner 760-739-3185 Jennifer.email@example.com|
|Sub-Investigator: Lori A Coleman, MD|
|Principal Investigator: P. Brian Volpp, MD, MPH|
|Sub-Investigator: Kelly D Dewitt, MD|
|Sub-Investigator: Barry Uhl, MD|
|Sub-Investigator: Geoffrey Weinstein, MD|
|Sub-Investigator: Phillip Zentner, MD|
|Principal Investigator:||P. Brian Volpp, MD, MPH||San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology|