Salvage Cryotherapy in Recurrent Prostate Cancer

Terminated

• Conditions: Recurrent Prostate Cancer

• Registration Number: NCT00824928
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Status Verified: 2010-06
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (17)

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Kaiser Permanente; 🇺🇸 Sacremento, California, United States

Prostate Institute of America; 🇺🇸 Ventura, California, United States

University of Colorado at Denver and Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Lakeland Regional Cancer Center; 🇺🇸 Lakeland, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Midwest Urology/RMD Clinical Research; 🇺🇸 Melrose Park, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

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