Clinical trial NCT00824928: Salvage Cryotherapy in Recurrent Prostate Cancer
Official title: A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Recurrent Prostate Cancer
Keywords: Prostate Cancer
Recurrent Prostate Cancer
Prostate Cancer Recurrence
Radiation Failure
Salvage Cryotherapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2009-01-19
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic Institutions and Community Urologic Oncology Clinics in the United States of America and the United Kingdom

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.


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

Primary outcomes:
measure: Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period).
timeFrame: 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:
measure: Percentage change in QoL scores (EPIC) if available
timeFrame: 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: Percentage change in AUA-symptom score (also referred to as IPSS score)
timeFrame: 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: Percentage change in erectile dysfunction as measured by Sexual Health Inventory for men score (SHIM also referred to as IIEF score)
timeFrame: 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: Percentage change in urinary symptoms (continence score)
timeFrame: 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
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Sacremento
country: United States
facility: Kaiser Permanente
state: California
city: Ventura
country: United States
facility: Prostate Institute of America
state: California
city: Aurora
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Melrose Park
country: United States
facility: Midwest Urology/RMD Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Brooklyn
country: United States
facility: Methodist Hospital
state: New York
city: New York
country: United States
facility: Nelson Stone (private practice)
state: New York
city: Columbus
country: United States
facility: Riverside Urology, Inc.
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital/Warren Alpert Medical School of Brown University
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute - Memphis
state: Tennessee
city: Arlington
country: United States
facility: Urology Associates of North Texas
state: Texas
city: Norfolk
country: United States
facility: Urology of Virginia, Sentara Medical Group
state: Virginia
Study officials:
affiliation: University of Colorado, Denver
name: Al Barqawi, MD
role: STUDY_CHAIR
affiliation: University of Colorado, Denver
name: David Crawford, MD
role: STUDY_CHAIR
References: