A Study to Evaluate MRI-guided Cryoablation for Focal Native Intermediate Grade Prostate Cancer

Overview

About this study

The purpose of this study is to investigate MR-guided cryoablation of biopsy proven Gleason 7 prostate cancers using the Galil MR-compatible cryoablation system to monitor the technqiue and prospectively collect the data. The system is already FDA (510k) approved for soft tissue ablation and has been utilized successfully at Mayo previously.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

- Patients with pacemaker or defibrillator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/23/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator David Woodrum, M.D., Ph.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Desirae Howe-Clayton (507) 255-0111 Howe.Desirae@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Woodrum, M.D., Ph.D.

Closed-enrolling by invitation

Contact information:

Desirae Howe-Clayton

(507) 255-0111

Howe.Desirae@mayo.edu

More information

Publications

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