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


N/A
30 Years
80 Years
Open (Enrolling)
Male
Recurrent Prostate Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period).

Outcome 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

Safety Issue:

No

Principal Investigator

Al Barqawi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

06-1040

NCT ID:

NCT00824928

Start Date:

January 2007

Completion Date:

December 2014

Related Keywords:

  • Recurrent Prostate Cancer
  • Prostate Cancer
  • Recurrent Prostate Cancer
  • Prostate Cancer Recurrence
  • Radiation Failure
  • Salvage Cryotherapy
  • Prostatic Neoplasms

Name

Location
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rush University Medical Center Chicago, Illinois  60612-3824
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Urology Associates of North Texas Arlington, Texas  76015
University of Tennessee Cancer Institute - Memphis Memphis, Tennessee  38104
Lakeland Regional Cancer Center Lakeland, Florida  33805
Kaiser Permanente Sacramento, California  
Loma Linda University Loma Linda, California  92354
University of Colorado at Denver and Health Sciences Center Aurora, Colorado  80045-0511
Urology of Virginia, Sentara Medical Group Norfolk, Virginia  23503
Prostate Institute of America Ventura, California  93003
Midwest Urology/RMD Clinical Research Melrose Park, Illinois  60160
Methodist Hospital Brooklyn, New York  11215
Nelson Stone (private practice) New York, New York  10021
Riverside Urology, Inc. Columbus, Ohio  43214
Rhode Island Hospital/Warren Alpert Medical School of Brown University Providence, Rhode Island  02904