MR-Guided Cryoablation of Prostate Bed Recurrences

NCT ID: NCT01727284

Last Updated: 2025-09-04

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-12

Study Completion Date

2026-11-30

Brief Summary

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The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

Detailed Description

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Conditions

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Prostate Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MR-guided cryoablation (freezing of tissue and/or tumors)

Patients undergo cryoablation using the Galil MR-compatible cryoablation system and MRI while on study.

Group Type EXPERIMENTAL

MR-guided cryoablation

Intervention Type PROCEDURE

Interventions

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MR-guided cryoablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa
* Surgery is not a desirable alternative therapy at the time of enrollment
* Radiation therapy has failed or not indicated or can be safely postponed
* Tumor size is \< 5 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Patient is able to undergo MRI

Exclusion Criteria

* N/A
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

Assistant Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Woodrum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2023-01699

Identifier Type: REGISTRY

Identifier Source: secondary_id

12-002245

Identifier Type: -

Identifier Source: org_study_id

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