MRI-Guided Cryoablation for Focal Native Prostate Cancer

Clinicaltrials.gov ID: NCT04797039
db-list-check Status RECRUITING
b-loader Phase
b-people Age 30 - 100 Years
b-bullseye-arrow Enrollments 100

Conditions

Primary Malignant Neoplasm of Prostate (Diagnosis)

Summary

The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed.Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.

Detailed Description

The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits.

The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor’s standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

Inclusion Criteria:

* Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
* Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
* Tumor size is < 2 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Patient is able to undergo MRI

Exclusion Criteria:

Study Plan

MR guided cryoablation

Focal MR guided cryoablation for low- to intermediate-grade prostate cancer

  • PROCEDURE:

    MR guided cryoablation

    Description:

    MR guided cryoablation of focal biopsy proven prostate cancer

Outcome Measures

Primary Outcome Measures

Technical success of the MR-guided cryoablation

Time Frame: Will assess for 5 years with interval assessment each year

Safety of the MR-guided cryoablation

Time Frame: Will assess for 5 years with interval assessment each year

Examine short term tumor recurrence

Time Frame: Will assess for 5 years with interval assessment each year

Secondary Outcome Measures

MR procedure time.

Time Frame: Will assess for 5 years with interval assessment each year

Timeline

  • Last Updated
    April 16, 2024
  • Start Date
    March 15, 2021
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    December 1, 2030

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