Study of Focal Cryoablation in Low-Risk Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00774436
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- 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
- 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
Exclusion Criteria:
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method To evaluate the change from baseline in quality-of-life indicators following focal cryoablation in patients with low-risk localized prostate cancer. conclusion of the study To evaluate treatment related tissue changes with ultrasound imaging at the 6-8 month patient office visit Ultrasound examination of the prostate performed at the time of biopsy procedures will be include archiving of 3D digital images to allow post-hoc analysis of the images to assess for tissue changes that may be characterized with imaging software.
Related Research Topics
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Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center🇺🇸New York, New York, United States