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

• Sponsor: University of Calgary (Other)
• Overall Status: Completed
• CT.gov ID: NCT00489060
• Collaborator: Canadian Cancer Trials Group (Other), AHS Cancer Control Alberta (Other)
• Enrollment: 244
• Location: 1
• Duration (Months): 112
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Cryoablation and External Beam Radiation	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 244 participants
• 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
• Study Start Date: Dec 1, 1997
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. No evidence of disease progression (NEDP) at 36 months [36 months]

Secondary Outcome Measures

1. Prostate biopsy status [36 months post treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinically localized prostate cancer

• PSA < 20ng/ml

• Negative bone scan

Exclusion Criteria:

• Previous TURP

• Previous hormone therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00489060
• Other Study ID Numbers: 9716
• First Posted: Jun 21, 2007
• Last Update Posted: Jul 17, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Cryoablation; Radiation; Prostate Cancer
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 17, 2008