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

U

University of Calgary

Status and phase

Completed
Phase 3

Conditions

Prostate Cancer

Treatments

Procedure: Cryoablation and External Beam Radiation

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

244 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Previous TURP
  • Previous hormone therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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