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Completed

NCT Number: NCT00489060

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Tom Baker Cancer Center

Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous TURP
  • Previous hormone therapy

Treatment and study plan

Cryoablation and External Beam Radiation

Procedure

Primary outcomes

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

    Time frame: 36 months

Secondary outcomes

  1. Prostate biopsy status

    Time frame: 36 months post treatment

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • AHS Cancer Control Alberta
  • Canadian Cancer Trials Group

Registry information

Official study title

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

Important dates

Study start
1997
Study completion
2007
First posted
Jun 21, 2007
Registry last updated
Jul 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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