Text Size

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

This study has been completed.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Alberta Health Services
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00489060
First received: June 20, 2007
Last updated: July 16, 2008
Last verified: July 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489060

Locations
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
NCIC Clinical Trials Group
Alberta Health Services
Investigators
Principal Investigator: Bryan Donnelly, MD Tom Baker Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00489060     History of Changes
Other Study ID Numbers: 9716
Study First Received: June 20, 2007
Last Updated: July 16, 2008
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on June 17, 2013