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Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

This study is currently recruiting participants.
Verified February 2013 by San Diego Radiosurgery
Sponsor:
Information provided by (Responsible Party):
San Diego Radiosurgery
ClinicalTrials.gov Identifier:
NCT00969202
First received: August 28, 2009
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Radiation: Stereotactic Radiosurgery using the Novalis Tx
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Diego Radiosurgery:

Primary Outcome Measures:
  • PSA decline measured through laboratory testing. [ Time Frame: One month following radiosurgery through 5 year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Novalis Tx
  • Novalis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969202

Contacts
Contact: Laura M Bauchert 760-739-3835 lbauchert@sdradiosurgery.com

Locations
United States, California
San Diego Radiosurgery at Palomar Medical Center Recruiting
Escondido, California, United States, 92025
Contact: Laura M Bauchert     760-739-3835     lbauchert@sdradiosurgery.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            
Sponsors and Collaborators
San Diego Radiosurgery
Investigators
Principal Investigator: P. Brian Volpp, MD, MPH San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
  More Information

No publications provided

Responsible Party: San Diego Radiosurgery
ClinicalTrials.gov Identifier: NCT00969202     History of Changes
Other Study ID Numbers: SDRS0001
Study First Received: August 28, 2009
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego Radiosurgery:
Prostate Cancer
Cancer of the Prostate
Prostate Tumor
Novalis Tx
 Novalis
Stereotactic Radiosurgery
Radiosurgery
Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013