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Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2015 by San Diego Radiosurgery
Information provided by (Responsible Party):
San Diego Radiosurgery Identifier:
First received: August 28, 2009
Last updated: November 17, 2015
Last verified: November 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 Intervention Phase
Prostate Cancer Radiation: Stereotactic Radiosurgery using the Novalis Tx Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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 ]

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. ]

Estimated Enrollment: 50
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)
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


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00969202

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

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
Principal Investigator: P. Brian Volpp, MD, MPH San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
  More Information

Responsible Party: San Diego Radiosurgery Identifier: NCT00969202     History of Changes
Other Study ID Numbers: SDRS0001
Study First Received: August 28, 2009
Last Updated: November 17, 2015

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 21, 2017