MR-Guided Laser Ablation of Prostate Bed Recurrences

NCT ID: NCT01743638

Last Updated: 2014-04-10

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to see if MR-guided laser ablation 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 Laser Ablation

Group Type EXPERIMENTAL

MR-Guided Laser Ablation

Intervention Type PROCEDURE

Interventions

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MR-Guided Laser Ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to Urology and/or Interventional Radiology for treatment.
* 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 ≤ 5 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Performance status is ECOG 2 or better in adults
* Patient is able to undergo MRI

Exclusion Criteria

* Patients with pacemaker or defibrillator
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 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, Mayo Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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09-001584

Identifier Type: -

Identifier Source: org_study_id

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