Salvage Cryotherapy in Recurrent Prostate Cancer

Recurrent Prostate Cancer Clinical Trial

— SCORE  

Official title:

A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00824928
• Other study ID #: 06-1040
• Status: Terminated
• Phase: N/A
• First received: January 15, 2009
• Last updated: May 26, 2015
• Start date: January 2007
• Est. completion date: December 2012

Study information

• Verified date: June 2010
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

Procedure:
• Cryoablation / Cryotherapy
Salvage Cryoablation of the prostate

Locations

Country	Name	City	State
United States	Urology Associates of North Texas	Arlington	Texas
United States	University of Colorado at Denver and Health Sciences Center	Aurora	Colorado
United States	Methodist Hospital	Brooklyn	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Riverside Urology, Inc.	Columbus	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Loma Linda University	Loma Linda	California
United States	Midwest Urology/RMD Clinical Research	Melrose Park	Illinois
United States	University of Tennessee Cancer Institute - Memphis	Memphis	Tennessee
United States	Nelson Stone (private practice)	New York	New York
United States	Urology of Virginia, Sentara Medical Group	Norfolk	Virginia
United States	Rhode Island Hospital/Warren Alpert Medical School of Brown University	Providence	Rhode Island
United States	Kaiser Permanente	Sacremento	California
United States	Prostate Institute of America	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Galil Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period).		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	No
Secondary	Percentage change in QoL scores (EPIC) if available		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	No
Secondary	Percentage change in AUA-symptom score (also referred to as IPSS score)		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	No
Secondary	Percentage change in erectile dysfunction as measured by Sexual Health Inventory for men score (SHIM also referred to as IIEF score)		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	No
Secondary	Percentage change in urinary symptoms (continence score)		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	No

External Links

•   Link