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Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
San Diego Radiosurgery

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Stereotactic Radiosurgery using the Novalis Tx Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. PSA decline measured through laboratory testing. [ Time Frame: One month following radiosurgery through 5 year follow up ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00969202

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Contact: Jennifer Joiner 760-739-3185
Contact: Jeremy Legg 615-920-1282

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United States, California
San Diego Radiosurgery at Palomar Medical Center Recruiting
Escondido, California, United States, 92025
Contact: Jennifer Joiner    760-739-3185   
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
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Principal Investigator: P. Brian Volpp, MD, MPH San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology

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Responsible Party: San Diego Radiosurgery Identifier: NCT00969202     History of Changes
Other Study ID Numbers: SDRS0001
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by San Diego Radiosurgery:
Prostate Cancer
Cancer of the Prostate
Prostate Tumor
Novalis Tx
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases