Primary Malignant Neoplasm of Prostate (Diagnosis)NCT04797039
MRI-Guided Cryoablation for Focal Native Prostate Cancer
An observational study of Primary Malignant Neoplasm of Prostate (Diagnosis), run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 100 years, men only
- Conditions the study is for
- Primary Malignant Neoplasm of Prostate (Diagnosis)
- What is being tested?
- MR guided cryoablation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male population 50-100 years old with biopsy confirmed localized low- to intermediate-grade cancer.
Who may be able to join
- 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
Who cannot join
- •
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Desirae Howe-Clayton, 507-255-0111, howe.desirae@mayo.edu
David Woodrum, M.D, Ph.D.
About this study
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.
Read the 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.
- Being tested
- MR guided cryoablation
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR guided cryoablationProcedure or surgery
Also called cryoablation
MR guided cryoablation of focal biopsy proven prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| MR guided cryoablation | Focal MR guided cryoablation for low- to intermediate-grade prostate cancer Receives: Procedure: MR guided cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the MR-guided cryoablation
Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation.
Measured: Will assess for 5 years with interval assessment each year
Safety of the MR-guided cryoablation
Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure.
Measured: Will assess for 5 years with interval assessment each year
Examine short term tumor recurrence
Examine short term tumor recurrence over 6 months with contrast enhanced MRI and as required MR or U/S guided biopsy of prostate bed if PSA biochemical recurrence.
Measured: Will assess for 5 years with interval assessment each year
Secondary outcomes (1)
MR procedure time.
We will examine the time for each step in the process to create a stream-lined process and minimize MR procedure time.
Measured: Will assess for 5 years with interval assessment each year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Dec 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Malignant Neoplasm of Prostate (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797039
- Sponsor's protocol ID
- 20-003822
- Status last verified
- May 2026
- First submitted
- 11 Mar 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No