Salvage Cryotherapy in Recurrent Prostate Cancer

Terminated

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Observational	Cryoablation / Cryotherapy	Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Locations (17): Barbara Ann Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
Nelson Stone (private practice)
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New York, New York, United States
Rush University Medical Center
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Chicago, Illinois, United States
Methodist Hospital
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Brooklyn, New York, United States
Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States
Riverside Urology, Inc.
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Columbus, Ohio, United States
Midwest Urology/RMD Clinical Research
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Melrose Park, Illinois, United States
Kaiser Permanente
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Sacremento, California, United States
Rhode Island Hospital/Warren Alpert Medical School of Brown University
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Providence, Rhode Island, United States
Urology of Virginia, Sentara Medical Group
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Norfolk, Virginia, United States
Loma Linda University
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Loma Linda, California, United States
University of Colorado at Denver and Health Sciences Center
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Aurora, Colorado, United States
Lakeland Regional Cancer Center
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Lakeland, Florida, United States
Prostate Institute of America
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Ventura, California, United States
Urology Associates of North Texas
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Arlington, Texas, United States
University of Tennessee Cancer Institute - Memphis
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Memphis, Tennessee, United States