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NCT04797039 | RECRUITING | Primary Malignant Neoplasm of Prostate (Diagnosis)

MRI-Guided Cryoablation for Focal Native Prostate Cancer
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

David A. Woodrum

Brief 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.

Condition or disease

Primary Malignant Neoplasm of Prostate (Diagnosis)

Intervention/treatment

MR guided cryoablation

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : MRI-Guided Cryoablation for Focal Native Prostate Cancer
Actual Study Start Date : 2020-12-01
Estimated Primary Completion Date : 2030-12
Estimated Study Completion Date : 2030-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 100 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
  • •
MRI-Guided Cryoablation for Focal Native Prostate Cancer

Location Details

NCT04797039

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905