Study of Focal Cryoablation in Low-Risk Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 15, 2008

Last Updated Date

November 12, 2009

Start Date ^ICMJE

October 2008

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00774436 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Focal Cryoablation in Low-Risk Prostate Cancer

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Procedure: focal cryotherapy

Study Arms / Comparison Groups

Experimental: 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 mapping 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Male

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: James Eastham, MD	646-422-4390
Contact: Jonathan Coleman, MD	646-422-4432

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00774436

Responsible Party

James Eastham, MD, Memorial Sloan-Kettering Cancer Center

Study ID Numbers ^ICMJE

08-118

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

James Eastham, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP