Study of Focal Cryoablation in Low-Risk Prostate Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00774436

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Procedure: focal cryotherapy	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To evaluate treatment related tissue changes with ultrasound imaging [ Time Frame: prior to performing the biopsy ] [ Designated as safety issue: No ]
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 [ Time Frame: at the 6-8 month patient office visit ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patients scheduled to receive 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.	Procedure: focal cryotherapy 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).

Arms

Assigned Interventions

Experimental: Patients scheduled to receive 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.

Procedure: focal cryotherapy

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).

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774436

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

James Eastham, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00774436 History of Changes
Other Study ID Numbers:	08-118
Study First Received:	October 15, 2008
Last Updated:	September 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

focal cryotherapy
low-risk prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012