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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Guided Cryoablation for Focal Native Prostate Cancer
- ClinicalTrials.gov ID
- NCT04797039
- Acronym / sponsor ID
- 20-003822
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR guided cryoablation | – | Procedure: MR guided cryoablationFocal MR guided cryoablation for low- to intermediate-grade prostate cancer |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male population 50-100 years old with biopsy confirmed localized low- to intermediate-grade cancer.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- •
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR guided cryoablationAlso: cryoablationMR guided cryoablation of focal biopsy proven prostate cancer | Procedure or surgery | MR guided cryoablation |
Primary outcome
Technical success of the MR-guided cryoablation
Time frame: Will assess for 5 years with interval assessment each year
Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation.
Safety of the MR-guided cryoablation
Time frame: Will assess for 5 years with interval assessment each year
Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure.
Examine short term tumor recurrence
Time frame: Will assess for 5 years with interval assessment each year
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.
1 secondary outcome
MR procedure time.
Time frame: Will assess for 5 years with interval assessment each year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Malignant Neoplasm of Prostate (Diagnosis), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desirae Howe-Clayton (507-255-0111, howe.desirae@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the MR-guided cryoablation (time frame: Will assess for 5 years with interval assessment each year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.