Study of Focal Cryoablation in Low-Risk Prostate Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/6/2018 |
| Start Date: | October 2008 |
| End Date: | October 2019 |
A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer
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.
amount of cancer within their prostate removed by freezing, called Focal Cryoablation or
Cryotherapy.
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
Inclusion Criteria:
- 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
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)
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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