Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer - Full Text View

Sponsor:	San Diego Radiosurgery
Information provided by (Responsible Party):	San Diego Radiosurgery
ClinicalTrials.gov Identifier:	NCT00969202

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 I

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:

MedlinePlus related topics: Cancer Prostate Cancer

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:	10
Study Start Date:	August 2009
Estimated Primary Completion Date:	August 2011 (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
Principal Investigator: Lori A Coleman, MD
Sub-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:

Lori A Coleman, MD

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:	August 29, 2011
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 February 09, 2012