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

University of Colorado, Denver17 sites in 1 country60 target enrollmentJanuary 2007

ConditionsRecurrent Prostate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Recurrent Prostate Cancer
Sponsor: University of Colorado, Denver
Enrollment: 60
Locations: 17
Primary Endpoint: Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period).
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

December 2012

Last Updated

10 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

University of Colorado, Denver

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)