SCORE: Salvage Cryotherapy in Recurrent Prostate Cancer

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00824928
• Collaborator: Boston Scientific Corporation (Industry)
• Enrollment: 60
• Locations: 17
• Duration (Months): 71
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Prostate Cancer	Procedure: Cryoablation / Cryotherapy

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

• University of Colorado, Denver
• Boston Scientific Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00824928
• Other Study ID Numbers: 06-1040
• First Posted: Jan 19, 2009
• Last Update Posted: May 27, 2015
• Last Verified: Jun 1, 2010

• 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; Recurrence

Study Results

No Results Posted as of May 27, 2015