Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

November 17, 2015 updated by: San Diego Radiosurgery

Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • San Diego Radiosurgery at Palomar Medical Center
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSA decline measured through laboratory testing.
Time Frame: One month following radiosurgery through 5 year follow up
One month following radiosurgery through 5 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
One month following radiosurgery through 5 years follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego Radiosurgery

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDRS0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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