Salvage Cryotherapy in Recurrent Prostate Cancer

NCT ID: NCT00824928

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational

Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy

Cryoablation / Cryotherapy

Intervention Type PROCEDURE

Salvage Cryoablation of the prostate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cryoablation / Cryotherapy

Salvage Cryoablation of the prostate

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Al Barqawi, MD

Role: STUDY_CHAIR

University of Colorado, Denver

David Crawford, MD

Role: STUDY_CHAIR

University of Colorado, Denver

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University

Loma Linda, California, United States

Site Status

Kaiser Permanente

Sacremento, California, United States

Site Status

Prostate Institute of America

Ventura, California, United States

Site Status

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Midwest Urology/RMD Clinical Research

Melrose Park, Illinois, United States

Site Status

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Methodist Hospital

Brooklyn, New York, United States

Site Status

Nelson Stone (private practice)

New York, New York, United States

Site Status

Riverside Urology, Inc.

Columbus, Ohio, United States

Site Status

Rhode Island Hospital/Warren Alpert Medical School of Brown University

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Tennessee Cancer Institute - Memphis

Memphis, Tennessee, United States

Site Status

Urology Associates of North Texas

Arlington, Texas, United States

Site Status

Urology of Virginia, Sentara Medical Group

Norfolk, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-1040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hemi-Gland Cryoablation for Prostate Cancer at UCLA
NCT03503643 ENROLLING_BY_INVITATION
Charité HT-Prostate
NCT04159051 UNKNOWN NA