MR-Guided Laser Ablation of Prostate Bed Recurrences | NCT01743638

Studies
MR-Guided Laser Ablation of Prostate Bed Recurrences

NCT01743638

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Apr 10, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Prostate Tumors

Interventions

MR-Guided Laser Ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Dec 4, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2014

Last Update Posted Date

Apr 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
MR-Guided Laser Ablation	Experimental		Procedure: MR-Guided Laser Ablation

Name	Type	Description	Arm Group Labels	Other Names
MR-Guided Laser Ablation	Procedure		MR-Guided Laser Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up		3-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David A. Woodrum, M.D., Ph.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided