Prostate TumorsNCT01727284
MR-Guided Cryoablation of Prostate Bed Recurrences
A study testing MR-guided cryoablation in people with Prostate Tumors, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences. Read more about this study
- Who is it for?
- Ages 30 to 100 years, men only
- Conditions the study is for
- Prostate Tumors
- What is being tested?
- MR-guided cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2012to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patients with "biopsy proven" soft tissue tumor or MRI/PET imaging convincing of recurrences of prostate fossa
- Surgery is not a desirable alternative therapy at the time of enrollment
- Radiation therapy has failed or not indicated or can be safely postponed
- Tumor size is < 5 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
- N/A
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences
The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.
- Conditions
- Prostate Tumors
- Being tested
- MR-guided cryoablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided cryoablationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MR-guided cryoablation (freezing of tissue and/or tumors) | Experimental | Patients undergo cryoablation using the Galil MR-compatible cryoablation system and MRI while on study. Receives: Procedure: MR-guided cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of target lesion at 3-6, 12, 18, 24, and 36 month imaging follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study start12 Dec 2012
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate TumorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
- Investigators
- David Woodrum, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727284
- Sponsor's protocol ID
- 12-002245
- Other IDs
- NCI-2023-01699
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2012
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences
- ClinicalTrials.gov ID
- NCT01727284
- Acronym / sponsor ID
- 12-002245
- Conditions
- Prostate Tumors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- 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 see if MR-guided cryoablation can effectively treat prostate tumor recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided cryoablation (freezing of tissue and/or tumors) | Experimental | Procedure: MR-guided cryoablationPatients undergo cryoablation using the Galil MR-compatible cryoablation system and MRI while on study. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with "biopsy proven" soft tissue tumor or MRI/PET imaging convincing of recurrences of prostate fossa
- Surgery is not a desirable alternative therapy at the time of enrollment
- Radiation therapy has failed or not indicated or can be safely postponed
- Tumor size is < 5 cm at its largest diameter
- Tumor does not encompass the rectal wall or external urethral sphincter
Key exclusion criteria (1 listed)
- N/A
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 cryoablation | Procedure or surgery | MR-guided cryoablation (freezing of tissue and/or tumors) |
Primary outcome
Evaluation of target lesion at 3-6, 12, 18, 24, and 36 month imaging follow-up
Time frame: 3 years
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 25 Sep 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.
David Woodrum, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided cryoablation in people with Prostate Tumors, 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 6 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: enrolling by invitation, as of the sponsor's last update on 25 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of target lesion at 3-6, 12, 18, 24, and 36 month imaging follow-up (time frame: 3 years). 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 25 Sep 2026.