Back to resultsA Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Cryoablation and External Beam Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Cryoablation, Radiation, Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Clinically localized prostate cancer
- PSA < 20ng/ml
- Negative bone scan
Exclusion Criteria:
- Previous TURP
- Previous hormone therapy
Sites / Locations
- Tom Baker Cancer Center
Outcomes
Primary Outcome Measures
No evidence of disease progression (NEDP) at 36 months
Secondary Outcome Measures
Prostate biopsy status
Full Information
NCT ID
NCT00489060
First Posted
June 20, 2007
Last Updated
July 16, 2008
Sponsor
University of Calgary
Collaborators
Canadian Cancer Trials Group, AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT00489060
Brief Title
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
Official Title
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
Collaborators
Canadian Cancer Trials Group, AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.
Detailed Description
Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value >1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Cryoablation, Radiation, Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Cryoablation and External Beam Radiation
Primary Outcome Measure Information:
Title
No evidence of disease progression (NEDP) at 36 months
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Prostate biopsy status
Time Frame
36 months post treatment
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically localized prostate cancer
PSA < 20ng/ml
Negative bone scan
Exclusion Criteria:
Previous TURP
Previous hormone therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Donnelly, MD
Organizational Affiliation
Tom Baker Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
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