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

July 16, 2008 updated by: University of Calgary

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

A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Procedure: Cryoablation and External Beam Radiation

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.

Study Type

Interventional

Enrollment (Actual)

244

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada
    - Tom Baker Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

Previous TURP
Previous hormone therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No evidence of disease progression (NEDP) at 36 months Time Frame: 36 months	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Prostate biopsy status Time Frame: 36 months post treatment	36 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

AHS Cancer Control Alberta

Canadian Cancer Trials Group

Investigators

Principal Investigator: Bryan Donnelly, MD, Tom Baker Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria