Study of Focal Cryoablation in Low-Risk Prostate Cancer
Phase 2
Completed
- Conditions
- Prostate Cancer
- Interventions
- Procedure: focal cryotherapy
- 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
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
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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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients scheduled to receive Focal Cryotherapy focal cryotherapy After enrollment, patients will undergo a repeat transrectal ultrasound- guided prostate biopsy (minimum of 12 cores) to confirm the low-risk nature of their cancer. For study purposes, patients must meet the original entry crieteria on this repeat biopsy. If the patient meets the repeat-biopsy enrollment criteria, they will be treated with focal cryotherapy, meaning cryoablation of the regions of the prostate containing cancer. Efficacy is defined as all negative biopsy cores at the site of the focal ablation on a repeat transrectal biopsy 6 months after cryoablation. At baseline (prior to the re-staging biopsy), 3 months after focal cryotherapy, and at 6 months after focal cryotherapy (prior to the repeat prostate biopsy used to define efficacy), the patient will complete quality of life questionnaires as standard for all patients in the Urology Service.
- 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.
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States