Clinical trial NCT04797039: MRI-Guided Cryoablation for Focal Native Prostate Cancer
Official title: MRI-Guided Cryoablation for Focal Native Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Malignant Neoplasm of Prostate (Diagnosis)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 100
Sex: MALE
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male population 50-100 years old with biopsy confirmed localized low- to intermediate-grade cancer.

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.

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.

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:

•

Primary outcomes:
measure: Technical success of the MR-guided cryoablation
timeFrame: Will assess for 5 years with interval assessment each year
measure: Safety of the MR-guided cryoablation
timeFrame: Will assess for 5 years with interval assessment each year
measure: Examine short term tumor recurrence
timeFrame: Will assess for 5 years with interval assessment each year
Secondary outcomes:
measure: MR procedure time.
timeFrame: Will assess for 5 years with interval assessment each year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: