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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 InstituteDetroit, Michigan  48201
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rush University Medical CenterChicago, Illinois  60612-3824
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Urology Associates of North TexasArlington, Texas  76015
University of Tennessee Cancer Institute - MemphisMemphis, Tennessee  38104
Lakeland Regional Cancer CenterLakeland, Florida  33805
Kaiser PermanenteSacramento, California  
Loma Linda UniversityLoma Linda, California  92354
University of Colorado at Denver and Health Sciences CenterAurora, Colorado  80045-0511
Urology of Virginia, Sentara Medical GroupNorfolk, Virginia  23503
Prostate Institute of AmericaVentura, California  93003
Midwest Urology/RMD Clinical ResearchMelrose Park, Illinois  60160
Methodist HospitalBrooklyn, 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 UniversityProvidence, Rhode Island  02904