Study Stopped
Study was ended due to low enrollment
Salvage Cryotherapy in Recurrent Prostate Cancer
SCORE
A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study
1 other identifier
observational
60
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2007
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 15, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 27, 2015
June 1, 2010
5.4 years
January 15, 2009
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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
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
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
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
Study Arms (1)
Observational
Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy
Interventions
Eligibility Criteria
Academic Institutions and Community Urologic Oncology Clinics in the United States of America and the United Kingdom
You may qualify if:
- Read \& understand informed consent related to this study including consenting and HIPPA authorization
- Undergone salvage cryotherapy of the prostate for recurrent prostate cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Boston Scientific Corporationcollaborator
Study Sites (17)
Loma Linda University
Loma Linda, California, 92354, United States
Kaiser Permanente
Sacremento, California, 95825, United States
Prostate Institute of America
Ventura, California, 93003, United States
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33804, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Midwest Urology/RMD Clinical Research
Melrose Park, Illinois, 60160, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Methodist Hospital
Brooklyn, New York, 11215, United States
Nelson Stone (private practice)
New York, New York, 10021, United States
Riverside Urology, Inc.
Columbus, Ohio, 43214, United States
Rhode Island Hospital/Warren Alpert Medical School of Brown University
Providence, Rhode Island, 02904, United States
Medical University of South Carolina
Charleston, South Carolina, 29572, United States
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, 38104, United States
Urology Associates of North Texas
Arlington, Texas, 76012, United States
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Al Barqawi, MD
University of Colorado, Denver
- STUDY CHAIR
David Crawford, MD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2009
First Posted
January 19, 2009
Study Start
January 1, 2007
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
May 27, 2015
Record last verified: 2010-06