MRI-guided Transurethral Ultrasound Ablation for Prostate Cancer

(TACT Trial)

Recruiting at 14 trial locations

Overseen By Tanya O'Neal

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Profound Medical Inc.

Must not be taking: 5-alpha reductase inhibitors

Disqualifiers: Diabetes, Bleeding disorder, UTI, others

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

Compensation: Varies

Number of Visits: 2

Duration: Short treatment time

150 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop using 5-alpha reductase inhibitors (5-ARIs) or hormone therapy at least 3 months before the baseline visit and during the study follow-up period. If you are on anticoagulant therapy, it must be temporarily reversed within 7 days prior to treatment.

What data supports the effectiveness of the treatment MRI-guided Transurethral Ultrasound Ablation for Prostate Cancer?

Research shows that MRI-guided Transurethral Ultrasound Ablation has been studied in men with localized prostate cancer, with favorable safety and precision reported at 12 months and continued positive outcomes at 3 years. This suggests the treatment can effectively target and treat prostate cancer with precision. ^{1 2 3 4 5}

Is MRI-guided Transurethral Ultrasound Ablation safe for humans?

MRI-guided Transurethral Ultrasound Ablation has been studied for safety in both prostate cancer and benign prostatic hyperplasia. Studies have shown favorable safety outcomes, with no major treatment-related adverse events reported in trials involving humans. ^{1 2 4 6 7}

How is MRI-guided Transurethral Ultrasound Ablation treatment different from other prostate cancer treatments?

MRI-guided Transurethral Ultrasound Ablation is unique because it uses real-time MRI to guide and monitor the precise delivery of ultrasound energy to heat and destroy prostate cancer tissue, minimizing damage to surrounding areas. This approach aims to reduce side effects compared to traditional treatments like surgery or radiation, offering a more targeted and less invasive option. ^{1 2 4 7 8}

Research Team

Scott E. Eggener

Principal Investigator

University of Chicago

Eligibility Criteria

Men aged 45-80 with localized prostate cancer, a Gleason score ≤3+4, PSA ≤15 ng/ml, and a prostate size within specific MRI measurements. They must be eligible for MRI and general anesthesia, have no major organ issues or severe bladder problems, not on certain medications like hormone therapy recently, and without prior prostate cancer treatments.

Inclusion Criteria

My prostate cancer has a Gleason score of 7 or less.

I am a man aged between 45 and 80.

My prostate cancer has a Gleason score of 3+4.

Exclusion Criteria

I have had trouble urinating in the past year.

I have been treated for prostatitis within the last 6 months.

My MRI shows a significantly enlarged median lobe of the prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided transurethral ultrasound ablation of prostate tissue

Short treatment time

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)

Treatment Details

Interventions

• MRI-guided Transurethral Ultrasound Ablation

Trial Overview The study is testing the safety and effectiveness of TULSA-PRO system which uses ultrasound guided by MRI to target and destroy prostate tissue in patients with localized prostate cancer. It's a single-arm trial involving about 150 men who will all receive this treatment.

Participant Groups

Group I: MRI-guided Transurethral Ultrasound Ablation Device Experimental Treatment 1 Intervention

Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue.

Who Is Running the Clinical Trial?

Profound Medical Inc.

Lead Sponsor

Trials

4

Recruited

1,400+

Findings from Research

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 prospective phase II trial involving 44 men with intermediate-risk prostate cancer, MRI-guided focal therapy using high-intensity focused ultrasound was found to be safe, with no major treatment-related adverse events reported.

At the 5-month follow-up, 93% of participants were free of clinically significant prostate cancer at the treatment site, indicating promising early oncologic outcomes, while functional outcomes related to erectile function and urinary symptoms remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. Ghai, S., Finelli, A., Corr, K., 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]

References

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

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer. [2021]

2. 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]

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

Evaluation of Focal Ablation of Magnetic Resonance Imaging Defined Prostate Cancer Using Magnetic Resonance Imaging Controlled Transurethral Ultrasound Therapy with Prostatectomy as the Reference Standard. [2019]

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

Magnetic resonance image guided transurethral ultrasound prostate ablation: a preclinical safety and feasibility study with 28-day followup. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Quantitative analysis of 3-D conformal MRI-guided transurethral ultrasound therapy of the prostate: theoretical simulations. [2009]

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

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. [2021]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

MR Imaging in Real Time Guiding of Therapies in Prostate Cancer. [2022]