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Study of Focal Cryoablation in Low-Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
focal cryotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring focal cryotherapy, low-risk prostate cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients scheduled to receive Focal Cryotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the change from baseline in quality-of-life indicators following focal cryoablation in patients with low-risk localized prostate cancer.
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.
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.

Full Information

First Posted
October 15, 2008
Last Updated
July 25, 2019
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00774436
Brief Title
Study of Focal Cryoablation in Low-Risk Prostate Cancer
Official Title
A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 14, 2008 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
July 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
focal cryotherapy, low-risk prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients scheduled to receive Focal Cryotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
focal cryotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Time Frame
conclusion of the study
Secondary Outcome Measure Information:
Title
To evaluate the change from baseline in quality-of-life indicators following focal cryoablation in patients with low-risk localized prostate cancer.
Time Frame
conclusion of the study
Title
To evaluate treatment related tissue changes with ultrasound imaging
Description
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.
Time Frame
prior to performing the biopsy
Title
To evaluate treatment related tissue changes with ultrasound imaging
Description
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.
Time Frame
at the 6-8 month patient office visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Eastham, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

Study of Focal Cryoablation in Low-Risk Prostate Cancer

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