Full Text View
Tabular View
No Study Results Posted
Related Studies
Prostate Conformal Cryotherapy
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, April 2009
First Received: April 7, 2009   No Changes Posted
Sponsors and Collaborators: M.D. Anderson Cancer Center
Endocare, Inc.
Gen-Probe, Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00877682
  Purpose
  1. To determine the efficacy and safety of regional cryoablation of the dominant prostate tumor as definitive therapy for clinical prostate cancer.

    • Efficacy is defined by the ability to identify and eradicate the clinically dominant cancer (biopsy proven eradication) within a planned treatment field.
    • Safety is defined as completion of procedures detailed without therapeutic complications requiring medical intervention.
  2. To measure Health Related Quality of Life (HRQOL) before and after regional prostate cryoablation.
  3. To assess the clinical utility of new prostate cancer specific marker.

Condition Intervention
Prostate Cancer
Procedure: Cryoablation

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Regional Cryoablation for Localized Adenocarcinoma of the Prostate

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if using cryotherapy to treat only the part of the prostate that contains cancer is an effective treatment for prostate cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cryotherapy: Experimental Procedure: Cryoablation
Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
  2. Serum PSA </= 10 ng/mL before prostate biopsy
  3. Less than 50% of samples from one side of the prostate positive for prostate cancer.
  4. No greater than 50% of a single core total length occupied by prostate cancer.
  5. No dominant Gleason 4 component. (e.g.; 4+X is not allowed, but X+4 is eligible)
  6. No Gleason 5 component (primary, secondary or tertiary).
  7. Subjects may have contralateral positive prostate biopsy in a single core within the eligibility biopsy so long as the involvement of this core is 2mm or less and no Gleason 4 or Gleason 5 pattern exists. This is considered to be Non-Dominant (Contralateral) Tumor Burden and is not exclusionary.

Exclusion Criteria:

  1. Medical History or Concurrent Disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. Investigator believes subject is unwilling or unable to comply with study protocol requirements.
  2. AUASI (American Urologic Association Symptom Index) score >/=20
  3. Active urinary tract infection
  4. Active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
  5. Medical or surgical castration initiated before or after the eligibility biopsy.
  6. Patient is unable to provide informed consent.
  7. Patients will undergo base line bone scan prior to cryoablation to evaluate for regions of abnormal uptake before therapeutic intervention.

Metastatic disease by bone scintigraphy is exclusionary.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877682

Contacts
Contact: John F. Ward, MD 713-792-3250

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: John F. Ward, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Endocare, Inc.
Gen-Probe, Inc.
Investigators
Principal Investigator: John F. Ward, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( John F. Ward, MD / Assistant Professor )
Study ID Numbers: 2008-0244
Study First Received: April 7, 2009
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00877682     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Prostate Tumor
Adenocarcinoma of the Prostate
PCA
Regional Prostate Cryoablation
Cryotherapy
Cryoablation
Health Related Quality of Life
HRQOL

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Anesthetics, General
Anesthetics
Quality of Life
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009