Prostate Cancer
Conditions
Keywords
Cryoablation, Radiation, Prostate Cancer
Brief summary
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.
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.
Interventions
PROCEDURECryoablation and External Beam Radiation
Sponsors
Canadian Cancer Trials Group
AHS Cancer Control Alberta
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Clinically localized prostate cancer * PSA \< 20ng/ml * Negative bone scan
Exclusion criteria
* Previous TURP * Previous hormone therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No evidence of disease progression (NEDP) at 36 months | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Prostate biopsy status | 36 months post treatment |
Countries
Canada
Outcome results
None listed