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


N/A
30 Years
N/A
Open (Enrolling)
Male
Prostate Tumors

Thank you

Trial Information

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


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

- Performance status is ECOG 2 or better in adults

- Patient is able to undergo MRI

Exclusion Criteria:

- Patients with pacemaker or defibrillator

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluation of target lesion at 3-6 month imaging follow-up

Outcome Time Frame:

3-6 months

Safety Issue:

Yes

Principal Investigator

David Woodrum, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-002245

NCT ID:

NCT01727284

Start Date:

November 2012

Completion Date:

January 2016

Related Keywords:

  • Prostate Tumors
  • Prostatic Neoplasms
  • Recurrence

Name

Location
Mayo Clinic in Rochester Rochester, Minnesota  55905