MRI-Guided Cryoablation for Focal Native Prostate Cancer

Mayo Clinic

Status: Enrolling

Conditions: Primary Malignant Neoplasm of Prostate (Diagnosis)

Treatments: Procedure: MR guided cryoablation

Study type: Observational

Funder types: Other

Identifiers

NCT04797039

20-003822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 30 to 100 years old

Volunteers: No Healthy Volunteers

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

•

Trial design

100 participants in 1 patient group

MR guided cryoablation

Description:

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

Treatment:

Procedure: MR guided cryoablation