Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
21–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
Men ≥ 21 years of age with a life expectancy estimated to be \> 10-years.
Diagnosis of adenocarcinoma of the prostate and confirmed by MSKCC review
No prior treatment for prostate cancer
ECOG performance status of 0 or 1
Prostate cancer clinical stage T1c-T2a
PSA \< 10ng/mL (this will be the PSA level prompting the prostate biopsy)
Prostate Size \<60 cc on transrectal ultrasound
Repeat transrectal prostate biopsy that must meet the following parameters:
Minimum of 12 biopsy cores
No Biopsy Gleason grade 4 or 5
Unilateral cancer (only right-sided or left-sided, not bilateral)
No more than 50% cancer in any one biopsy core
No more than 25% of cores containing cancer
You may not be if
Medically unfit for anesthesia
Histology other than adenocarcinoma
Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
Men who are currently receiving anticoagulant drugs (e.g.: Coumadin, warfarin)
Second Step Enrollment
Medically unfit for anesthesia
Histology other than adenocarcinoma
Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)
Clareo Health | Study of Focal Cryoablation in Low-Risk Prostate Cancer
