Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00969202|
Recruitment Status : Unknown
Verified November 2015 by San Diego Radiosurgery.
Recruitment status was: Recruiting
First Posted : September 1, 2009
Last Update Posted : November 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Stereotactic Radiosurgery using the Novalis Tx||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||December 2016|
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.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|