A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer
A two-step consenting process will be in place for all patients being enrolled to this
study. The two-step method is necessary because all patients being enrolled will need to
have a repeat transrectal biopsy after meeting the initial study requirements. The two
step consent process would enroll patients considering focal cryotherapy into the initial
part of the study (QOL assessment at baseline, PCA3 test, and repeat biopsy); those deemed
eligible after the re-staging biopsy would be consented to participate in the remainder of
the study (focal cryotherapy, QOL studies, repeat biopsy at 6 months for efficacy, PCA3
test).
First Step Enrollment
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the local oncologic efficacy of focal cryoablation in men with low-risk, clinically localized prostate cancer, as measured by the ability to obtain all negative biopsy cores at the site of focal ablation of the cancer.
conclusion of the study
No
James Eastham, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
08-118
NCT00774436
October 2008
October 2013
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |