Prostate Conformal Cryotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Endocare, Inc.
Gen-Probe, Incorporated
FirmaMed
Envisioneering Medical Technologies
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00877682
First received: April 7, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The goal of this clinical research study is to learn if using cryotherapy to treat only the part of the prostate that contains cancer is an effective treatment for prostate cancer. The safety of this treatment will also be studied. Researchers also want to learn if treating only the part of the prostate with cancer causes less impact on your quality of life than other types of therapies.


Condition Intervention
Prostate Cancer
Procedure: Cryoablation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regional Cryoablation for Localized Adenocarcinoma of the Prostate

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient Response (Result of biopsy at 6 months after therapy) [ Time Frame: At 6-month, 18-month or 36-month post-treatment biopsy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryotherapy
Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.
Procedure: Cryoablation
Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.
Other Name: Cryotherapy

Detailed Description:

Cryotherapy (also called cryoablation) is an FDA approved treatment for prostate cancer. It involves placing multiple needles within the prostate and freezing the prostate, which will destroy both the cancerous and normal prostate tissue in a very controlled manner. It is possible to treat less than the whole prostate by only freezing the area of the prostate known to contain the cancer.

For this study, cryotherapy will be performed in a way similar to whole prostate cryotherapy, except the entire prostate will not be frozen. For this study, only that portion of the prostate with the most prostate cancer and the upper half of the opposite side of location of the cancer in the prostate will be treated. All areas of cancer may not be treated.

Cryotherapy:

Cryotherapy is performed under general anesthetic in the operating room. An ultrasound probe is inserted into the rectum to monitor the tissue freezing. A urethral warmer is inserted into the bladder through the penis to maintain the health of the urethra.

Quality-of-Life Questionnaires:

You will complete quality-of-life questionnaires before the prostate biopsy, and then at 3, 6, 12, 18, 24, 30, and 36 months after cryotherapy. The questionnaires will ask about your general health and your urinary, bowel, and sexual functions. The questionnaire should take about 15 minutes to complete each time.

Digital Rectal Exams and PCA3 Testing:

Before your cryotherapy and again before the biopsies at Months 6, 18 and 36 you will have a digital rectal exam (feeling the prostate through your anus) to check the status of the disease. You will also have digital rectal exams at Months 48 and 60 to check the status of the disease.

Urine will be collected after each digital rectal exam. This sample will be tested for PCA3, which has been associated with prostate cancer.

Prostate Biopsies:

You will have additional prostate biopsies at 6, 18, and 36 months after cryotherapy. About 12 biopsies samples will be collected each time from the same locations as during the screening biopsy. If you have rising PSA levels or your doctor thinks it is necessary, you and your doctor will discuss the need additional biopsies at Months 48 and 60.

This is an investigational study. Cryotherapy is FDA approved for the destruction of tissue, including prostate tissue. For the treatment of prostate cancer, it is commonly used to treat the entire prostate gland. This study is investigational because only a part of the prostate gland will be treated, instead of the entire gland. Partial organ treatment with cryotherapy is common for treatment of kidney, liver, and skin lesions.

Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

  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.
  8. In the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy.

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. Bone scans performed within 12 months prior to study entry will be used for study base line purposes and will not need to be repeated, unless clinically indicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00877682     History of Changes
Other Study ID Numbers: 2008-0244
Study First Received: April 7, 2009
Last Updated: February 10, 2014
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

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014