Salvage Cryotherapy in Recurrent Prostate Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Recurrent Prostate Cancer

Intervention / Treatment
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* Procedure: Cryoablation / Cryotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy | Procedure: Cryoablation / Cryotherapy<br>* Salvage Cryoablation of the prostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Recurrent Prostate Cancer, Prostate Cancer Recurrence, Radiation Failure, Salvage Cryotherapy