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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	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 and quality-of-life questionnaires	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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 ]

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Patients scheduled to receive Focal Cryotherapy: Experimental After enrollment, pt's will undergo a mapping prostate bx as currently performed at our institution. Those men meeting the mapping-biopsy criteria will subsequently be treated with focal cryotherapy. Patients will be evaluated through the standard quality-of-life questionnaires, that are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).	Procedure: focal cryotherapy and quality-of-life questionnaires Eligible patients will be scheduled to receive Focal Cryotherapy on the prostate. The procedure will be schedule to be done within 12 weeks of the initial transperineal prostate biopsy. The patient will return to clinic approximately 1 week, after treatment, for catheter removal. Also the patient will have follow-up visits about 6 weeks, 3 months, and 6 months, after focal cryotherapy, at which time a physical exam with digital rectal examination, PSA test, and Quality of Life questionnaires (except for week 6) will be performed. A repeat transperineal mapping biopsy will be done at 6 months after Focal Cryotherapy.

Arms

Assigned Interventions

Patients scheduled to receive Focal Cryotherapy: Experimental

After enrollment, pt's will undergo a mapping prostate bx as currently performed at our institution. Those men meeting the mapping-biopsy criteria will subsequently be treated with focal cryotherapy. Patients will be evaluated through the standard quality-of-life questionnaires, that are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).

Procedure: focal cryotherapy and quality-of-life questionnaires

Eligible patients will be scheduled to receive Focal Cryotherapy on the prostate. The procedure will be schedule to be done within 12 weeks of the initial transperineal prostate biopsy. The patient will return to clinic approximately 1 week, after treatment, for catheter removal. Also the patient will have follow-up visits about 6 weeks, 3 months, and 6 months, after focal cryotherapy, at which time a physical exam with digital rectal examination, PSA test, and Quality of Life questionnaires (except for week 6) will be performed. A repeat transperineal mapping biopsy will be done at 6 months after Focal Cryotherapy.

Eligibility

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

Criteria

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
Baseline mapping prostate biopsy must meet the pre-enrollment biopsy parameterser

Pre-enrollment biopsy parameters (as per MSKCC review):

Minimum of 10 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

Contacts

Contact: James Eastham, MD		easthamj@mskcc.org
Contact: Jonathan Coleman, MD		colemaj1@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: James Eastham, MD easthamj@mskcc.org
Contact: Jonathan Coleman, MD colemaj1@mskcc.org
Principal Investigator: James Eastham, MD

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 ( James Eastham, MD )
Study ID Numbers:	08-118
Study First Received:	October 15, 2008
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00774436 History of Changes
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:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009