Salvage Cryotherapy in Recurrent Prostate Cancer - Full Text View

Sponsor:	University of Colorado, Denver
Collaborator:	Galil Medical
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00824928

Purpose

To provide a systemic, uniform and user-friendly tool for collection of data on prostate cancer salvage cryotherapy in a multicenter setting. The goal is to learn more about the short and long term efficacy and safety of this procedure. Ultimately the data analysis will serve as a robust guidance instrument for improving upon the utilization of this procedure for the treatment of patients with recurrent (LRD) prostate cancer.

Condition	Intervention
Recurrent Prostate Cancer	Procedure: Cryoablation / Cryotherapy

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period). [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage change in QoL scores (EPIC) if available [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]
Percentage change in AUA-symptom score (also referred to as IPSS score) [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]
Percentage change in erectile dysfunction as measured by Sexual Health Inventory for men score (SHIM also referred to as IIEF score) [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]
Percentage change in urinary symptoms (continence score) [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	January 2007

Groups/Cohorts	Assigned Interventions
Observational Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy	Procedure: Cryoablation / Cryotherapy Salvage Cryoablation of the prostate

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Academic Institutions and Community Urologic Oncology Clinics in the United States of America and the United Kingdom

Criteria

Inclusion Criteria:

Read & understand informed consent related to this study including consenting and HIPPA authorization
Undergone salvage cryotherapy of the prostate for recurrent prostate cancer

Exclusion Criteria:

Patients who underwent radical prostatectomy as their primary therapy or other significant surgery (except prostatic biopsy)
Patients with clinically confirmed distant metastasis (unless deemed beneficial by the treating physician)
Any previous major rectal surgery
Clinically significant lower urinary tract or rectal anomalies
Existing urethral, rectal, or bladder fistulae

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824928

Contacts

Contact: Al Barqawi, MD

720-848-0922

al.barqawi@ucdenver.edu

Locations

United States, California
Loma Linda University	Recruiting
Loma Linda, California, United States, 92354
Contact: Forrest Jellison fcjellison@hotmail.com
Principal Investigator: Herbert Ruckle, MD
Kaiser Permanente	Recruiting
Sacremento, California, United States, 95825
Contact: Deepak Chabra, MD 916-973-5355
Principal Investigator: Deepak Chabra, MD
Prostate Institute of America	Recruiting
Ventura, California, United States, 93003
Contact: Dana Vaughn 805-585-3082 dvaughan@cmhhospital.org
Principal Investigator: Duke Bahn, MD
United States, Colorado
University of Colorado at Denver and Health Sciences Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Al Barqawi, MD 720-848-1800 al.barqawi@ucdenver.edu
Principal Investigator: Al Barqawi, MD
Principal Investigator: E. David Crawford, MD
United States, Florida
Lakeland Regional Cancer Center	Recruiting
Lakeland, Florida, United States, 33804
Contact: Robin Stewart, RN, PhD, OCN, CCRC 863-904-1877 robin.stewart@lrmc.com
Principal Investigator: Byron Hodge, MD
United States, Illinois
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael Abern, MD 312-942-6000 ext 3004 Michael_Abern@rush.edu
Principal Investigator: Charles F. McKiel, MD
Midwest Urology/RMD Clinical Research	Recruiting
Melrose Park, Illinois, United States, 60160
Contact: Michelle Johnson 708-681-4810 rmdresearch@sbcglobal.net
Principal Investigator: Richard G. Harris, MD
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Rhoda Loman 317-274-1791 Rloman@iupui.edu
Principal Investigator: Tom Gardner, MD
United States, Michigan
Barbara Ann Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Martha Heath 313-576-8426 HeathM@karmanos.org
Principal Investigator: Michael Cher, MD
United States, New York
Methodist Hospital	Recruiting
Brooklyn, New York, United States, 11215
Contact: Celeste Egan 718-230-7788 ceganburg@gmail.com
Principal Investigator: Ivan Grunberger, MD
Nelson Stone (private practice)	Recruiting
New York, New York, United States, 10021
Contact: Sydney Ratnow 212-535-0755 ssratnow@aol.com
Principal Investigator: Nelson Stone, MD
United States, Ohio
Riverside Urology, Inc.	Recruiting
Columbus, Ohio, United States, 43214
Contact: Mary Ann Miller 614-442-3000 miller_maryann@hotmail.com
Principal Investigator: Herbert Riemenschneider, MD
United States, Rhode Island
Rhode Island Hospital/Warren Alpert Medical School of Brown University	Recruiting
Providence, Rhode Island, United States, 02904
Contact: Betsy Parrot 401-272-7799 ext 1214 bparrott@urologyri.com
Principal Investigator: Gyan Pareek, MD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29572
Contact: Jessica Jenkins 843-876-0630 jenkijn@musc.edu
Principal Investigator: Harry Clarke, MD
United States, Tennessee
University of Tennessee Cancer Institute - Memphis	Recruiting
Memphis, Tennessee, United States, 38104
Contact: Cindy Herrington 901-448-7194 cherrington@uthsc.edu
Principal Investigator: Robert Wake, MD
United States, Texas
Urology Associates of North Texas	Recruiting
Arlington, Texas, United States, 76012
Contact: Lynette A. Karasz 817-465-8715 ext 173 lkarasz@uant.com
Principal Investigator: David S. Ellis, MD
United States, Virginia
Urology of Virginia, Sentara Medical Group	Recruiting
Norfolk, Virginia, United States, 23502
Contact: April Whitely 757-457-5168 ALWHITLE@sentara.com
Principal Investigator: Robert Given, MD

Sponsors and Collaborators

University of Colorado, Denver

Galil Medical

Investigators

Study Chair:	Al Barqawi, MD	University of Colorado, Denver
Study Chair:	David Crawford, MD	University of Colorado, Denver

More Information

No publications provided

Responsible Party:	Albaha Barqawi, MD, University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00824928 History of Changes
Other Study ID Numbers:	06-1040
Study First Received:	January 15, 2009
Last Updated:	June 11, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:

Prostate Cancer
Recurrent Prostate Cancer
Prostate Cancer Recurrence
Radiation Failure
Salvage Cryotherapy

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