MRI-Guided Cryoablation for Focal Native Prostate Cancer

April 15, 2024 updated by: David A. Woodrum, Mayo Clinic

The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed.

Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits.

The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • David Woodrum, M.D, Ph.D.
        • Contact:

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

Ages Eligible for Study

30 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male population 50-100 years old with biopsy confirmed localized low- to intermediate-grade cancer.

Description

Inclusion Criteria:

  • Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
  • Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
  • Tumor size is < 2 cm at its largest diameter
  • Tumor does not encompass the rectal wall or external urethral sphincter
  • Patient is able to undergo MRI

Exclusion Criteria:

•

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MR guided cryoablation
Focal MR guided cryoablation for low- to intermediate-grade prostate cancer
Procedure: MR guided cryoablation
MR guided cryoablation of focal biopsy proven prostate cancer
Other Names:
  • cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of the MR-guided cryoablation
Time Frame: Will assess for 5 years with interval assessment each year
Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation.
Will assess for 5 years with interval assessment each year
Safety of the MR-guided cryoablation
Time Frame: Will assess for 5 years with interval assessment each year
Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure.
Will assess for 5 years with interval assessment each year
Examine short term tumor recurrence
Time Frame: Will assess for 5 years with interval assessment each year
Examine short term tumor recurrence over 6 months with contrast enhanced MRI and as required MR or U/S guided biopsy of prostate bed if PSA biochemical recurrence.
Will assess for 5 years with interval assessment each year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR procedure time.
Time Frame: Will assess for 5 years with interval assessment each year
We will examine the time for each step in the process to create a stream-lined process and minimize MR procedure time.
Will assess for 5 years with interval assessment each year

Collaborators and Investigators

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

Sponsor

Mayo Clinic

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)

December 1, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-003822

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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