Prostate Conformal Cryotherapy

January 29, 2018 updated by: M.D. Anderson Cancer Center

Regional Cryoablation for Localized Adenocarcinoma of the Prostate

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Cryotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Response
Time Frame: 6 months
Result of biopsy at 6 months after therapy. A failure event is either a Failure of Patient Selection or a Failure of Treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gen-Probe, Incorporated
Endocare, Inc.
FirmaMed
Envisioneering Medical Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John F. Ward, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008-0244
  • NCI-2011-01340 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Cryoablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings