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A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489060
First Posted: June 21, 2007
Last Update Posted: July 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Cancer Trials Group
AHS Cancer Control Alberta
Information provided by:
University of Calgary
  Purpose
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.

Condition Intervention Phase
Prostate Cancer Procedure: Cryoablation and External Beam Radiation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • No evidence of disease progression (NEDP) at 36 months [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Prostate biopsy status [ Time Frame: 36 months post treatment ]

Enrollment: 244
Study Start Date: December 1997
Study Completion Date: April 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically localized prostate cancer
  • PSA < 20ng/ml
  • Negative bone scan

Exclusion Criteria:

  • Previous TURP
  • Previous hormone therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489060


Locations
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Canadian Cancer Trials Group
AHS Cancer Control Alberta
Investigators
Principal Investigator: Bryan Donnelly, MD Tom Baker Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00489060     History of Changes
Other Study ID Numbers: 9716
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: July 17, 2008
Last Verified: July 2008

Keywords provided by University of Calgary:
Cryoablation
Radiation
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases