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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489060
• Other study ID #: 9716
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2007
• Last updated: July 16, 2008
• Start date: December 1997
• Est. completion date: April 2007

Study information

• Verified date: July 2008
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinically localized prostate cancer

• PSA < 20ng/ml

• Negative bone scan

Exclusion Criteria:

• Previous TURP

• Previous hormone therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Cryoablation and External Beam Radiation

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	AHS Cancer Control Alberta, Canadian Cancer Trials Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No evidence of disease progression (NEDP) at 36 months		36 months
Secondary	Prostate biopsy status		36 months post treatment