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

NCT ID: NCT00489060

Last Updated: 2008-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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Cryoablation Radiation Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cryoablation and External Beam Radiation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous TURP
* Previous hormone therapy
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Trials Group

NETWORK

Sponsor Role collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Principal Investigators

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Bryan Donnelly, MD

Role: PRINCIPAL_INVESTIGATOR

Tom Baker Cancer Center

Locations

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Tom Baker Cancer Center

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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9716

Identifier Type: -

Identifier Source: org_study_id