MRI-Guided Cryoablation for Focal Native Prostate Cancer

NCT ID: NCT04797039

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Malignant Neoplasm of Prostate (Diagnosis)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MR guided cryoablation

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

MR guided cryoablation

Intervention Type PROCEDURE

MR guided cryoablation of focal biopsy proven prostate cancer

Interventions

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MR guided cryoablation

MR guided cryoablation of focal biopsy proven prostate cancer

Intervention Type PROCEDURE

Other Intervention Names

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cryoablation

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David A. Woodrum

M.D, Ph.D, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Desirae Howe-Clayton

Role: CONTACT

507-255-0111

Facility Contacts

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Desirae Howe-Clayton

Role: primary

507-255-0111

Related Links

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Other Identifiers

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20-003822

Identifier Type: -

Identifier Source: org_study_id

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