Salvage Cryotherapy in Recurrent Prostate Cancer (SCORE)

May 26, 2015 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Sacremento, California, United States, 95825
        • Kaiser Permanente
      • Ventura, California, United States, 93003
        • Prostate Institute of America
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado at Denver and Health Sciences Center
    • Florida
      • Lakeland, Florida, United States, 33804
        • Lakeland Regional Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Melrose Park, Illinois, United States, 60160
        • Midwest Urology/RMD Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • Brooklyn, New York, United States, 11215
        • Methodist Hospital
      • New York, New York, United States, 10021
        • Nelson Stone (private practice)
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Urology, Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Rhode Island Hospital/Warren Alpert Medical School of Brown University
    • South Carolina
      • Charleston, South Carolina, United States, 29572
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Cancer Institute - Memphis
    • Texas
      • Arlington, Texas, United States, 76012
        • Urology Associates of North Texas
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Urology of Virginia, Sentara Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy
Procedure: Cryoablation / Cryotherapy
Salvage Cryoablation of the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Time Frame
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
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)
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
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)
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
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Boston Scientific Corporation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-1040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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