MR-Guided Cryoablation for Recurrent Prostate Cancer

Overseen By Deb Berg

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

107 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is MR-guided cryoablation safe for treating recurrent prostate cancer?

MR-guided cryoablation for recurrent prostate cancer appears to be generally safe, with most complications being minor. In a study of 114 patients, 32.4% experienced complications, but 89.1% of these were minor. Patients who had previous prostate surgery had a higher risk of complications. ^{1 2 3 4 5}

How is MR-guided cryoablation different from other treatments for recurrent prostate cancer?

MR-guided cryoablation is unique because it uses magnetic resonance imaging (MRI) to precisely target and freeze cancerous tissue in the prostate, which can reduce side effects compared to traditional treatments like surgery or radiation. This method is particularly beneficial for patients who have already undergone treatments like radical prostatectomy or radiation therapy, as it offers a less invasive option with potentially fewer complications. ^{2 5 6 7 8}

What data supports the effectiveness of the treatment MR-guided cryoablation for recurrent prostate cancer?

Research shows that MR-guided cryoablation is effective and safe for treating recurrent prostate cancer, with a 1-year recurrence-free survival rate of 76% and a 5-year rate of 25.1%. It also delays the need for additional treatments, with a 1-year treatment-free survival rate of 91.5% and a 5-year rate of 58.2%. ^{2 5 6 9 10}

Who Is on the Research Team?

David Woodrum, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with prostate cancer that has come back and shows up in the area where the prostate used to be. The tumor must be smaller than 5 cm, not involve certain areas like the rectal wall, and patients should be healthy enough for MRI scans. It's aimed at those who can't have or don't want surgery right now, and whose cancer hasn't responded to or isn't suitable for radiation therapy.

Inclusion Criteria

Surgery is not a good option for my condition right now.

My tumor does not involve the rectal wall or the external urethral sphincter.

Radiation therapy didn't work or isn't suitable for me right now.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo MR-guided cryoablation using the Galil MR-compatible cryoablation system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• MR-guided cryoablation

Trial Overview The study is testing MR-guided cryoablation—a way of freezing tumors using magnetic resonance imaging to guide the process—to see if it's effective in treating prostate cancer recurrences located where the prostate was previously removed.

How Is the Trial Designed?

Group I: MR-guided cryoablation (freezing of tissue and/or tumors) Experimental Treatment 1 Intervention

Patients undergo cryoablation using the Galil MR-compatible cryoablation system and MRI while on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided cryoablation of recurrent prostate cancer after radical prostatectomy: initial single institution experience. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

MRI-Guided Salvage Focal Cryoablation: A 10-Year Single-Center Experience in 114 Patients with Localized Recurrent Prostate Cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Focal Salvage MR Imaging-Guided Cryoablation for Localized Prostate Cancer Recurrence after Radiotherapy: 12-Month Follow-up. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

MR imaging-guided focal cryoablation in patients with recurrent prostate cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Medium Term Outcomes of Focal Cryoablation for Intermediate and High Risk Prostate Cancer: MRI and PSA are Not Predictive of Residual or Recurrent Disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Percutaneous MR-guided whole-gland prostate cancer cryoablation: safety considerations and oncologic results in 30 consecutive patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Oncologic Outcomes of Magnetic Resonance Imaging-Guided Cryoablation of Renal Cell Carcinoma: A 10-Year Single-Center Experience. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

MRI- Versus CT-Guided Renal Tumor Cryoablation: Is There a Difference? [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous MR-guided focal cryoablation for recurrent prostate cancer following radiation therapy: retrospective analysis of iceball margins and outcomes. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous MR-guided cryoablation of prostate cancer: initial experience. [2022]