TULSA-PRO Ablation for Prostate Cancer

(CARE Trial)

Recruiting at 4 trial locations

Overseen By Arthi Rajamohan

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Profound Medical Inc.

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

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding how TULSA-PRO, a treatment using ultrasound to target and treat prostate tissue, affects men in real-world settings. Researchers aim to assess the safety and effectiveness of this procedure, as well as its impact on patients' quality of life over time. Men undergoing this procedure as part of their standard care and who can provide consent are suitable candidates for this trial. As a Phase 4 trial, this research explores how the already FDA-approved and proven effective treatment benefits more patients, offering valuable insights for those considering participation.

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

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 transurethral ultrasound ablation (TULSA) procedure is safe?

Research has shown that the TULSA procedure is generally safe. The FDA has approved it for certain medical situations, indicating its safety. Studies have found that most people tolerate the TULSA procedure well. Common temporary side effects include urgent urination, discomfort, or, in rare cases, infection. These side effects typically resolve quickly. One study examined results six months post-procedure and found it safe for most people, with no significant or lasting harm. Overall, evidence suggests that TULSA is a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for prostate conditions, which often involve surgery, radiation, or medication, Transurethral Ultrasound Ablation (TULSA) offers a non-invasive approach. TULSA uses precise ultrasound energy delivered through the urethra to target and destroy prostate tissue, minimizing damage to surrounding areas. This method aims to reduce side effects like incontinence and erectile dysfunction, which are common in more invasive procedures. Researchers are excited about TULSA because it promises quicker recovery times and potentially improved quality of life for patients.

What evidence suggests that the transurethral ultrasound ablation (TULSA) procedure is effective?

Research has shown that transurethral ultrasound ablation (TULSA) is a promising treatment for prostate cancer. Studies found that a year after treatment, 91% of patients did not need pads, and 96% did not experience leaks. Importantly, 79% of patients avoided more aggressive treatments like radiation or surgery for five years. TULSA also provides lasting cancer control while keeping patients safe and maintaining their normal functions. However, some patients may experience side effects like erectile dysfunction, which affected 21% of patients but decreased to 17% after six months. Overall, TULSA shows strong potential in effectively managing prostate cancer. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Male

Candidate for TULSA-PRO treatment

willing and able to sign the Informed Consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

TULSA Procedure

Patients undergo the TULSA Procedure as part of their routine clinical care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the TULSA Procedure

Lifelong, with specific follow-ups at 3 months, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years, and annually thereafter

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transurethral Ultrasound Ablation (TULSA)

Who Is Running the Clinical Trial?

Profound Medical Inc.

Lead Sponsor

Trials

4

Recruited

1,400+

Citations

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

1‐year clinical outcomes of a phase II study - PMC Conclusions. Transurethral ultrasound ablation appears to be a safe and effective experimental treatment for BPO, demonstrating clinically ...

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

158 real-world efficacy of mri-guided transurethral ... Among patients with minimum 12 months follow-up, 91% are pad-free, and 96% leak-free (EPIC). By 6 months, 21% reported erectile dysfunction, ongoing in 17% by ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10464407/

First experiences using transurethral ultrasound ablation ... For example, 9/29 patients had clinically significant PCa and 7/29 clinically insignificant PCa 12 months after whole-gland TULSA, which results ...

5. grandroundsinurology.com grandroundsinurology.com/transurethral-ultrasound-guided-prostate-ablation-tulsa-clinical-trials-and-real-world-results/

Transurethral Ultrasound Guided Prostate Ablation (TULSA) He references five-year data showing that 79% of patients avoided salvage treatments like radiation or surgery. Ongoing improvements in TULSA's ...

6. tulsaprocedure.com tulsaprocedure.com/tulsa-procedure/about-tulsa-procedure/tulsa-procedure-benefits-risks/

TULSA Procedure Benefits & Risks The TULSA Procedure is FDA cleared, has more than 20 clinical publications with up to a 5-year outcomes. This procedure is incision-free and is performed as an ...

7. prostatelasercenter.com prostatelasercenter.com/blog/what-are-the-common-side-effects-of-the-tulsa-procedure/

What Are the Common Side Effects of the TULSA Procedure? What Are the Common Side Effects of the TULSA Procedure? · Short-term effects: Temporary urinary urgency, discomfort, and rarely infections.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31062122/

Single-Center Evaluation of 6-month Treatment Safety and ... Conclusion: TULSA demonstrated acceptable clinical safety in Phase I trial. Intensified treatment parameters in the TACT Pivotal trial increased ablation ...

9. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.16795

Magnetic resonance imaging‐guided transurethral ultrasound ... This prospective early phase II study demonstrates that TULSA is a safe and effective treatment for BPO, offering significant improvements in ...

10. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/43/NCT02766543/Prot_SAP_001.pdf

Clinical Protocol Summary Evaluation of the TULSA-PRO MRI-guided transurethral ultrasound prostate ablation device in patients with localized prostate cancer. Protocol. Number. GCP ...