Recurrent Prostate Cancer
Conditions
Keywords
Prostate Cancer, Recurrent Prostate Cancer, Prostate Cancer Recurrence, Radiation Failure, Salvage Cryotherapy
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.
Interventions
PROCEDURECryoablation / Cryotherapy
Salvage Cryoablation of the prostate
Sponsors
Boston Scientific Corporation
University of Colorado, Denver
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed