Study of Focal Cryoablation in Low-Risk Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00774436
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 12
- Starts
- 2008-10-14
- Expected to finish
- 2019-07-23
- Last updated by the study team
- 2019-07-29
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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 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)
- 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
You may not qualify 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)
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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