MRI-guided Transurethral Ultrasound Ablation for Prostate Cancer

(TACT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using MRI-guided ultrasound to target and destroy prostate tissue in men with localized prostate cancer. The goal is to assess the safety and effectiveness of this treatment for patients whose cancer remains confined to the prostate. The study seeks men diagnosed with prostate cancer, confirmed by biopsy, whose cancer has not advanced beyond certain stages. It presents a promising option for those who have not previously received definitive treatment for prostate cancer and meet other specific health criteria. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for 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 prior data suggests that this MRI-guided transurethral ultrasound ablation is safe for prostate cancer treatment?

Research has shown that MRI-guided transurethral ultrasound ablation (TULSA) is generally well-tolerated by patients. A study with a five-year follow-up found the procedure safe over time, without significant long-term problems. Another study reported one-year results, indicating that most patients did not experience severe side effects.

Overall, while some minor side effects, such as temporary discomfort or mild urinary issues, were noted, major complications were uncommon. This suggests the treatment is safe for many people with localized prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, MRI-guided Transurethral Ultrasound Ablation offers a non-invasive approach. This technique uses precise ultrasound waves directed by MRI imaging to target and ablate prostate tissue, minimizing damage to surrounding areas. Researchers are excited because this method could potentially reduce side effects and recovery time compared to traditional treatments, offering a more focused and gentle alternative for patients.

What evidence suggests that this MRI-guided transurethral ultrasound ablation is effective for prostate cancer?

Research has shown that MRI-guided transurethral ultrasound ablation (TULSA) is a promising treatment for localized prostate cancer. One study found that five years after a single TULSA procedure, patients maintained lasting cancer control, safety, and function. Another study reported that one year after treatment, patients experienced positive results in controlling prostate cancer while maintaining a good safety profile. This treatment may help patients avoid surgery and improve their quality of life by precisely targeting and destroying prostate tissue. TULSA uses real-time imaging and focused ultrasound waves, offering a non-invasive option for those with localized prostate cancer. ^{3 4 6 7 8}

Who Is on the Research Team?

Scott E. Eggener

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

Citations

1. 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 ...

2. 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).

3. jvir.org jvir.org/article/S1051-0443(23)01064-3/fulltext

Abstract No. 135 Five-Year Outcomes After MRI-Guided ... 5-year follow-up demonstrates durable oncologic control, safety, and functional preservation after a single whole-gland TULSA procedure.

4. 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 ...

5. eu-openscience.europeanurology.com eu-openscience.europeanurology.com/article/S2666-1683(24)01423-X/fulltext

Salvage Magnetic Resonance Imaging–guided ... This phase 2 study evaluates the outcomes of salvage magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (sTULSA).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12343988/

1‐year clinical outcomes of a phase II study - PMC To evaluate the safety and efficacy of magnetic resonance imaging (MRI)‐guided transurethral ultrasound ablation (TULSA) as a minimally invasive ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S266616832401423X

Prostate Cancer Salvage Magnetic Resonance Imaging ... This phase 2 study evaluates the outcomes of salvage magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (sTULSA).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8579125/

Single-Center Evaluation of Treatment Success Using Two ... Two-year follow-up demonstrated the efficacy of TULSA for the treatment of localized prostate cancer, and the durability of PSA and functional outcomes.