MR-Guided Laser Ablation of Prostate Bed Recurrences

Prostate Tumors Clinical Trial

Official title:

Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01743638
• Other study ID #: 09-001584
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2012
• Last updated: April 9, 2014
• Start date: April 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 95 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Tumors
• Prostatic Neoplasms

Intervention

Procedure:
• MR-Guided Laser Ablation

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up		3-6 months	Yes