Status:
COMPLETED
Study of Focal Cryoablation in Low-Risk Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if men, with low-risk prostate, can have the small amount of cancer within their prostate removed by freezing, called Focal Cryoablation or Cryotherapy.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Inclusion Criteria:
- 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
Key Trial Info
Start Date :
October 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00774436
Start Date
October 14 2008
End Date
July 23 2019
Last Update
July 29 2019
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065