Back to resultsCyberKnife Radiosurgery for Locally Recurrent Prostate CA
Primary Purpose
Recurrent Prostate Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
- Karnofsky performance status >80.
- Greater than 5 year life expectancy
- Greater than 2 years since the original course of radiotherapy.
- Absence of distant metastases by radiologic or pathologic assessment.
- Absence of lymph node involvement by radiologic or pathologic assessment.
- Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
- Stage T4 disease (AJCC 6th Edition, see Appendix II).
- Less than 2 years since the original course of radiotherapy.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
- Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- History of inflammatory bowel disease
- Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy
Sites / Locations
- CybeKnife Centers of San DiegoRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CyberKnife Radiosurgery
Arm Description
Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.
Outcomes
Primary Outcome Measures
Establish pattern of PSA decline
Secondary Outcome Measures
Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer
Full Information
NCT ID
NCT00851916
First Posted
February 25, 2009
Last Updated
July 18, 2017
Sponsor
CyberKnife Centers of San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00851916
Brief Title
CyberKnife Radiosurgery for Locally Recurrent Prostate CA
Official Title
VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CyberKnife Centers of San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.
This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CyberKnife Radiosurgery
Arm Type
Other
Arm Description
Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Radiosurgery
Intervention Description
CyberKnife Radiosurgery
Primary Outcome Measure Information:
Title
Establish pattern of PSA decline
Time Frame
Post CyberKnife Radiosurgery - 5 year f/up
Secondary Outcome Measure Information:
Title
Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer
Time Frame
Post CyberKnife Radiosurgery/5 yr. f/up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
Karnofsky performance status >80.
Greater than 5 year life expectancy
Greater than 2 years since the original course of radiotherapy.
Absence of distant metastases by radiologic or pathologic assessment.
Absence of lymph node involvement by radiologic or pathologic assessment.
Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
Stage T4 disease (AJCC 6th Edition, see Appendix II).
Less than 2 years since the original course of radiotherapy.
Lymph node involvement (N1).
Evidence of distant metastases (M1).
Radical surgery for carcinoma of the prostate
Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
History of inflammatory bowel disease
Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlyn Tripp
Phone
619-230-0400
Ext
224
Email
ctripp@rmgmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald B Fuller, M.D.
Organizational Affiliation
CyberKnife Centers of San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
CybeKnife Centers of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald B. Fuller, M.D.
12. IPD Sharing Statement
Learn more about this trial
CyberKnife Radiosurgery for Locally Recurrent Prostate CA
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