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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MR-guided cryoablation, a technique that freezes and destroys cancerous tissue, can effectively treat recurring prostate cancer. This new approach uses MRI to guide the freezing of prostate tumors that have returned after initial treatment. The trial may suit individuals who have found surgery and radiation therapy ineffective or unsuitable, have a tumor smaller than 5 cm, and can undergo an MRI. As an unphased trial, it offers patients the chance to explore a novel treatment option that could potentially address their specific condition.

Will I have to stop taking my current medications?

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

What prior data suggests that MR-guided cryoablation is safe for treating recurrent prostate cancer?

Research has shown that MR-guided cryoablation is safe for treating recurrent prostate cancer. In one study, only 10.9% of patients experienced temporary side effects, which resolved without long-term issues. This method freezes cancer cells while preserving healthy tissue, reducing the risk of serious complications. Overall, MR-guided cryoablation is considered safe and generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MR-guided cryoablation for recurrent prostate cancer because it offers a precise and minimally invasive approach to treat tumors. Unlike traditional options like surgery or radiation, this method uses extreme cold to freeze and destroy cancerous tissue while being guided in real-time by MRI imaging. This precision reduces damage to surrounding healthy tissue and may lead to fewer side effects and quicker recovery times for patients.

What evidence suggests that MR-guided cryoablation is effective for recurrent prostate cancer?

Research has shown that MR-guided cryoablation, the treatment under study in this trial, can effectively treat recurrent prostate cancer. In one study, patients experienced a significant drop in PSA levels, a marker used to monitor prostate cancer. Another study found that the cancer did not grow or return in the treated area for at least a year. Cryoablation freezes and destroys cancer cells while preserving healthy tissue, reducing side effects. These findings suggest that MR-guided cryoablation offers a promising option for treating prostate cancer recurrences. ^{1 4 6 7 8}

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.

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

My prostate cancer has returned and is confirmed by a biopsy.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452144/

MRI-Guided Salvage Focal Cryoablation: A 10-Year Single ... This therapy aims to treat the cancer selectively while preserving the rest of the prostatic gland and thereby minimizing the risk of treatment toxicity.

2. jvir.org jvir.org/article/S1051-0443(15)01466-9/fulltext

Magnetic resonance imaging-guided cryoablation of ... IRB approved single arm study to examine the effectiveness of MR guided cryoablation for locally recurrent prostate cancer after primary prostectomy.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28409355/

Percutaneous MR-guided focal cryoablation for recurrent ... Significantly improved local progression-free survival at 1 year post focal cryoablation was seen between patients with iceball margin >10 mm ( ...

4. interventionalnews.com interventionalnews.com/study-shows-significant-psa-reduction-with-cryoablation-for-recurrent-prostate-cancer/

Study shows “significant” PSA reduction with cryoablation ... Sotoudehnia summarised that their data shows cryoablation to be effective in reducing PSA in patients with recurrent prostate cancer. On ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044324004093

Magnetic Resonance Imaging–Guided Cryoablation of ... MR imaging–guided percutaneous cryoablation of metastatic LNs is a safe and technically effective technique for treating metastatic prostate cancer in LNs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7592492/

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

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04797039?tab=history&a=6

MRI-Guided Cryoablation for Focal Native Prostate Cancer 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 ...

8. esmed.org esmed.org/MRA/mra/article/view/5779

Woodrum-MR-guided focal therapy for native and recurrent ... The following manuscript reviews the current state of MR imaging, biopsy and MR-guided prostate ablations for native and recurrent prostate ...