Study of Focal Cryoablation in Low-Risk Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: focal cryotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients scheduled to receive Focal Cryotherapy<br>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. | Procedure: focal cryotherapy<br>* Those men meeting the re-staging biopsy criteria will subsequently be treated with focal cryotherapy. Clinical follow-up visits will be scheduled at 6 + 2 weeks, 3 + 1 months and 6 + 1 months after focal cryotherapy, at which time, a digital rectal examination and PSA test will be performed. Standard quality-of-life questionnaires, are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | prior to performing the biopsy | 
| To evaluate treatment related tissue changes with ultrasound imaging | 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. | at the 6-8 month patient office visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focal cryotherapy, low-risk prostate cancer