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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.

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 data supports the effectiveness of the treatment MRI-Guided Transurethral Ultrasound Ablation (TULSA) for prostate cancer?

Research shows that MRI-guided transurethral ultrasound ablation (TULSA) can effectively reduce prostate cancer tissue, with a study reporting a reduction of more than 75% in 8 out of 9 patients. Additionally, patients experienced no major urinary or gastrointestinal side effects, suggesting the treatment is both effective and safe for low-to-intermediate-risk prostate cancer. ^{1 2 3 4 5}

Is MRI-guided ultrasound ablation safe for treating prostate conditions?

MRI-guided ultrasound ablation, also known as TULSA, has shown favorable safety outcomes in studies for treating localized prostate cancer, with no major urinary or gastrointestinal side effects and no changes in erectile function observed in patients. ^{1 2 3 4 5}

How is MRI-Guided Ultrasound Ablation different from other prostate cancer treatments?

MRI-Guided Ultrasound Ablation (TULSA) is unique because it uses MRI to precisely guide ultrasound waves to heat and destroy prostate tissue, offering a minimally invasive option with potentially fewer side effects compared to traditional surgery or radiation. ^{1 2 3 4 6}

Research Team

David A Woodrum, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Acute and subacute prostate MRI findings after MRI-guided transurethral ultrasound ablation of prostate cancer. [2021]

2. Switzerland 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. [2018]

3. England 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. [2021]

4. England 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. [2022]

5. United States 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. [2020]

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

Single center retrospective analysis of fifty-two prostate cancer patients with customized MR-guided transurethral ultrasound ablation (TULSA). [2022]