MRI-Guided Ultrasound Ablation for Prostate Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Urinary infection, Proctitis, Bladder stones, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, minimally invasive treatment for prostate cancer using MRI-guided ultrasound ablation. The goal is to determine if this procedure can safely and effectively destroy cancer cells in men with low to intermediate-grade prostate cancer, potentially eliminating the need for surgery. It suits men diagnosed with specific types of prostate cancer who have not yet undergone treatment. As an unphased trial, this study allows patients to contribute to groundbreaking research that could lead to less invasive treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the MRI-guided TULSA procedure is safe for treating prostate cancer?

Research has shown that MRI-guided transurethral ultrasound ablation (TULSA) is generally safe for treating prostate cancer. Studies have found that this procedure maintains a good safety record, with no major side effects related to the treatment reported. It serves as a safe alternative to more traditional prostate cancer treatments. This less invasive procedure targets and destroys cancerous tissue, potentially eliminating the need for surgery. These findings suggest that the TULSA procedure is well-tolerated by patients and aims to improve the quality of life for those with prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MRI-guided transurethral ultrasound ablation (TULSA) is unique because it offers a non-invasive way to target prostate cancer using ultrasound waves precisely guided by MRI imaging. Unlike standard treatments like surgery or radiation, which can affect surrounding healthy tissue, MRI-guided TULSA focuses ultrasound energy only on cancerous areas, potentially reducing side effects. Researchers are excited about this treatment because it combines the precision of MRI with the therapeutic power of ultrasound, aiming to improve patient outcomes with fewer complications and a quicker recovery time.

What evidence suggests that the MRI-guided TULSA procedure is effective for prostate cancer?

Research has shown that MRI-guided transurethral ultrasound ablation (TULSA), which participants in this trial will undergo, can effectively reduce prostate cancer in many patients. One study found that 76% of patients had no detectable cancer one year after the procedure, and the average prostate size was reduced by 92%. Other studies indicate that while some patients experienced a return of cancer, many did not need further treatment for at least a year. This suggests TULSA could be a promising option for those wanting to avoid traditional surgery while effectively managing their prostate cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

David A Woodrum, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Men aged 45-80 with intermediate-grade prostate cancer (Gleason grade 2 or 3) that hasn't spread beyond the prostate and is suitable for MRI. They should have a life expectancy over 10 years, no prior treatments, and be able to undergo MRI and anesthesia. Exclusions include severe urinary problems, certain implants, infections, or conditions affecting device insertion.

Inclusion Criteria

I am a man aged between 45 and 80 and expected to live more than 10 years.

My treatment plan involves targeting a small area near the urethra, confirmed by a recent MRI.

I have not received any treatment for my condition.

Exclusion Criteria

I currently have a urinary tract infection or prostatitis that hasn't healed.

I am not considered a candidate for radical prostatectomy.

History of anal or rectal fibrosis or stenosis, urethral stenosis, or other abnormality challenging insertion of devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo MRI-guided TULSA procedure for prostate cancer treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

8 visits (in-person) at 3, 6, 9, 12, 15, 18, 21, and 24 months

Quality of Life Assessment

Assessment of patient-reported metrics for quality of life and return to normal activity

24 months

Multiple assessments (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• MRI-Guided Transurethral Ultrasound Ablation

Trial Overview The trial tests MRI-guided TULSA for treating intermediate prostate cancer. It's less invasive than surgery and uses ultrasound to heat and destroy cancer cells. The study also assesses how this treatment affects patients' quality of life through questionnaires.

How Is the Trial Designed?

Group I: Treatment (MRI-guided TULSA) Experimental Treatment 8 Interventions

Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.

MRI-Guided Transurethral Ultrasound Ablation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as TULSA for:

• Intermediate grade prostate cancer

Approved in Canada as TULSA for:

• Low-grade prostate cancer
• Intermediate grade prostate cancer

Approved in European Union as TULSA for:

• Localized prostate cancer

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 9 men with low-to-intermediate-risk prostate cancer, the TULSA procedure achieved over 75% reduction in cancer in 8 out of 9 patients, indicating strong efficacy.

The procedure was found to be safe, with no major urinary or gastrointestinal side effects and no changes in erectile firmness reported after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial. Sundaram, KM., Staruch, R., Burtnyk, M., et al.[2020]

In a study involving six men with localized prostate cancer, MRI-guided transurethral ultrasound ablation (TULSA) showed significant changes in MRI findings, including increased prostate and non-perfused volumes one and three weeks post-treatment.

The optimal timing for follow-up MRI after TULSA is suggested to be three weeks, as this allows for the reduction of post-procedural edema and maturation of non-perfused volume, while diffusion-weighted imaging provided limited additional diagnostic value during this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and subacute prostate MRI findings after MRI-guided transurethral ultrasound ablation of prostate cancer. Mäkelä, P., Anttinen, M., Suomi, V., et al.[2021]

In a study of 52 men with localized prostate cancer, MR-guided transurethral ultrasound ablation (TULSA) demonstrated an 88% early treatment success rate, defined by negative MRI results and no PSA recurrence, indicating its efficacy in treating prostate cancer.

TULSA was also effective for patients with concurrent benign prostate hyperplasia (BPH), with 83% reporting symptom improvement, while maintaining a favorable safety profile with only two Grade IIIa adverse events and no bowel complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single center retrospective analysis of fifty-two prostate cancer patients with customized MR-guided transurethral ultrasound ablation (TULSA). Lumiani, A., Samun, D., Sroka, R., et al.[2022]

MRI-guided transurethral ultrasound ablation (MRI-TULSA) is a safe and feasible method for whole-gland prostate ablation in localized prostate cancer, with a low incidence of serious adverse events and no rectal injuries reported among the 30 patients studied over 12 months.

The treatment showed promising efficacy, with an 87% reduction in PSA levels at one month and a significant decrease in cancer length in biopsies, indicating potential for effective disease control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Chin, JL., Billia, M., Relle, J., et al.[2018]

In a 3-year follow-up of a Phase I study involving 30 men with localized prostate cancer, MRI-guided transurethral ultrasound ablation (TULSA) showed no new serious adverse events, and urinary and bowel functions remained stable, indicating a favorable safety profile.

The treatment resulted in a significant reduction in PSA levels, with a median nadir of 0.33 ng/mL, and while 34% of patients had clinically significant disease at follow-up, TULSA allowed for effective salvage therapy without complications, demonstrating its efficacy and precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided transurethral ultrasound ablation in patients with localised prostate cancer: 3-year outcomes of a prospective Phase I study. Nair, SM., Hatiboglu, G., Relle, J., et al.[2021]

In a phase I study involving 10 men, MRI-guided transurethral ultrasound ablation (TULSA) demonstrated safety with no severe adverse events and significant improvements in urinary symptoms, with an 82% reduction in the International Prostate Symptom Score (IPSS) after 12 months.

TULSA also led to a 101% increase in maximum urinary flow rate and a 33% reduction in prostate volume, while maintaining sexual and bowel functions, indicating its efficacy as a treatment for benign prostatic obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study. Viitala, A., Anttinen, M., Wright, C., et al.[2022]

Citations

1. pubs.rsna.org pubs.rsna.org/doi/10.1148/rycan.259015

Clinical Outcomes of MRI-guided Transurethral US ... A 12-month follow-up biopsy showed clinically significant prostate cancer in 43.5% (10 of 23) of patients. Despite this, the safety profile was ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9231661/

A Systematic Review - PMC PD17-03 Five-year outcomes from a prospective Phase I study of MRI-guided transurethral ultrasound ablation in men with localized prostate cancer. J Urol ...

3. sirweb.org sirweb.org/for-press/new-treatment-option-for-prostate-cancer-shows-successful-outcomes/

New treatment option for prostate cancer shows successful ... Cancer was undetectable on follow up biopsy by 76% at one year after TULSA with a decrease in median prostate volume by 92% within one year and a decrease in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143924009414

158 real-world efficacy of mri-guided transurethral ... Here we report baseline characteristics and efficacy and safety outcomes at 1-year post-treatment for the subgroup treated for primary prostate cancer (PCa).

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40441432/

Magnetic Resonance Imaging-guided Transurethral ... Results: At 12 months, 43.5% of patients (10/23) had CSC on biopsy, with a recurrence-free survival rate of 40% and a treatment-free survival rate of 72% after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05438563

MRI-guided Transurethral Urethral Ultrasound Ablation for ... The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life. Detailed Description. PRIMARY ...