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Study was ended due to low enrollment
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation / Cryotherapy | Procedure | Salvage Cryoablation of the prostate |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Academic Institutions and Community Urologic Oncology Clinics in the United States of America and the United Kingdom
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| Name | Affiliation | Role |
|---|---|---|
| Al Barqawi, MD | University of Colorado, Denver | Study Chair |
| David Crawford, MD | University of Colorado, Denver | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States | ||
| Kaiser Permanente |
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| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |
| Sacremento |
| California |
| 95825 |
| United States |
| Prostate Institute of America | Ventura | California | 93003 | United States |
| University of Colorado at Denver and Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33804 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Midwest Urology/RMD Clinical Research | Melrose Park | Illinois | 60160 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Nelson Stone (private practice) | New York | New York | 10021 | United States |
| Riverside Urology, Inc. | Columbus | Ohio | 43214 | United States |
| Rhode Island Hospital/Warren Alpert Medical School of Brown University | Providence | Rhode Island | 02904 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29572 | United States |
| University of Tennessee Cancer Institute - Memphis | Memphis | Tennessee | 38104 | United States |
| Urology Associates of North Texas | Arlington | Texas | 76012 | United States |
| Urology of Virginia, Sentara Medical Group | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
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