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Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery using the Novalis Tx
Sponsored by
San Diego Radiosurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Cancer of the Prostate, Prostate Tumor, Novalis Tx, Novalis, Stereotactic Radiosurgery, Radiosurgery, Radiation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Diego Radiosurgery at Palomar Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Radiosurgery using NovalisTx

Arm Description

Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.

Outcomes

Primary Outcome Measures

PSA decline measured through laboratory testing.

Secondary Outcome Measures

Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.

Full Information

First Posted
August 28, 2009
Last Updated
November 17, 2015
Sponsor
San Diego Radiosurgery
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1. Study Identification

Unique Protocol Identification Number
NCT00969202
Brief Title
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
Official Title
Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Diego Radiosurgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Cancer of the Prostate, Prostate Tumor, Novalis Tx, Novalis, Stereotactic Radiosurgery, Radiosurgery, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Radiosurgery using NovalisTx
Arm Type
Experimental
Arm Description
Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery using the Novalis Tx
Other Intervention Name(s)
Novalis Tx, Novalis
Intervention Description
Five treatments given every other day.
Primary Outcome Measure Information:
Title
PSA decline measured through laboratory testing.
Time Frame
One month following radiosurgery through 5 year follow up
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Joiner
Phone
760-739-3185
Email
Jennifer.joiner@palomarhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Legg
Phone
615-920-1282
Email
jlegg@Allianceoncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. Brian Volpp, MD, MPH
Organizational Affiliation
San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego Radiosurgery at Palomar Medical Center
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Joiner
Phone
760-739-3185
Email
Jennifer.joiner@palomarhealth.org
First Name & Middle Initial & Last Name & Degree
Lori A Coleman, MD
First Name & Middle Initial & Last Name & Degree
P. Brian Volpp, MD, MPH
First Name & Middle Initial & Last Name & Degree
Kelly D Dewitt, MD
First Name & Middle Initial & Last Name & Degree
Barry Uhl, MD
First Name & Middle Initial & Last Name & Degree
Geoffrey Weinstein, MD
First Name & Middle Initial & Last Name & Degree
Phillip Zentner, MD

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

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