Recruiting

Cryoablation

Sponsor:

Mayo Clinic

Code:

NCT04797039

Conditions

Primary Malignant Neoplasm of Prostate (Diagnosis)

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

MR guided cryoablation

Study Details

Brief summary:

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.

Conditions

Primary Malignant Neoplasm of Prostate (Diagnosis)

Study ID

NCT04797039

Start date

Dec 1, 2020

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

MR guided cryoablation

Focal MR guided cryoablation for low- to intermediate-grade prostate cancer

Interventions

MR guided cryoablation

MR guided cryoablation of focal biopsy proven prostate cancer

Primary outcome measure

  • Technical success of the MR-guided cryoablation [ Time Frame: 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 ]
  • Examine short term tumor recurrence [ Time Frame: Will assess for 5 years with interval assessment each year ]

Central Contacts and Locations

Central contacts

Desirae Howe-Clayton

507-255-0111howe.desirae@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Desirae Howe-Clayton

507-255-0111howe.desirae@mayo.edu

Principal Investigator:

David Woodrum, M.D, Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-07.