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NCT Number: NCT04797039

MRI-Guided Cryoablation for Focal Native Prostate Cancer

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.

Recruiting

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Key information

Age range

30 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

David Woodrum, M.D, Ph.D.

PRINCIPAL_INVESTIGATOR

Desirae Howe-Clayton

CONTACT

[email protected]

507-255-0111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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

Treatment and study plan

MR guided cryoablation

Procedure

MR guided cryoablation of focal biopsy proven prostate cancer

Other names: cryoablation

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Desirae Howe-Clayton

CONTACT

[email protected]

507-255-0111

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Mar 15, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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