- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969202
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jennifer Joiner
- Phone Number: 760-739-3185
- Email: Jennifer.joiner@palomarhealth.org
Study Contact Backup
- Name: Jeremy Legg
- Phone Number: 615-920-1282
- Email: jlegg@Allianceoncology.com
Study Locations
-
-
California
-
Escondido, California, United States, 92025
- Recruiting
- San Diego Radiosurgery at Palomar Medical Center
-
Contact:
- Jennifer Joiner
- Phone Number: 760-739-3185
- Email: Jennifer.joiner@palomarhealth.org
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Five treatments given every other day.
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: P. Brian Volpp, MD, MPH, San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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