High Intensity Focused Ultrasound for Benign Prostatic Hyperplasia

(HIFU for BOO Trial)

Overseen By Ping Ting Yan

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Anticoagulants, Antiplatelets, NSAIDs, Immunosuppressants

Disqualifiers: Obesity, Latex allergy, Prostate calcification, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called High Intensity Focused Ultrasound (HIFU) for men with urinary problems due to an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH). The main goal is to determine if HIFU can effectively reduce symptoms like frequent or difficult urination. Researchers will also monitor for any side effects and assess improvements in overall urinary flow and comfort. Men who have struggled with these symptoms, especially if other treatments haven't worked or aren't suitable, might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for those seeking alternatives.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications like anticoagulants, antiplatelet agents, NSAIDs, and immunosuppressants before treatment. If you are unable to stop these medications, you may not be eligible for the trial.

What prior data suggests that this HIFU therapy is safe for treating benign prostatic hyperplasia?

Research has shown that High Intensity Focused Ultrasound (HIFU) is generally safe for treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Studies have found that HIFU can improve urinary symptoms with few serious side effects. Most patients feel better after the treatment, experiencing only mild discomfort such as temporary pain or swelling.

A review of studies found that people treated with HIFU had significant improvements in their symptoms. The procedure is well-tolerated and poses fewer risks compared to other treatments. Another study confirmed that HIFU reduces symptoms and slightly improves urine flow, indicating its safety.

Overall, while some mild side effects might occur, HIFU is considered a safe option for managing BPH symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

High Intensity Focused Ultrasound (HIFU) is unique because it offers a non-invasive approach to treating benign prostatic hyperplasia (BPH). Unlike traditional treatments like medication, which can have systemic side effects, or surgery, which involves significant recovery time, HIFU uses precise ultrasound waves to ablate the excess prostate tissue causing urinary problems. This method could potentially reduce recovery time and lower the risk of complications, making it an appealing option for patients suffering from BPH. Researchers are excited about HIFU because it represents a shift towards more targeted, less invasive treatment options for prostate issues.

What evidence suggests that High Intensity Focused Ultrasound is effective for benign prostatic hyperplasia?

Research has shown that High Intensity Focused Ultrasound (HIFU) therapy can effectively treat benign prostatic hyperplasia (BPH), a condition where the prostate gland enlarges. In this trial, participants will receive HIFU therapy to evaluate its effectiveness in treating BPH. Studies have found that patients experience significant symptom improvements, as measured by the International Prostate Symptom Score (IPSS), following HIFU treatment. Improvements in urine flow and overall quality of life have been observed at 3, 6, and 12 months post-procedure. This suggests that HIFU can be a promising option for reducing the bothersome symptoms of BPH. Additionally, the treatment removes prostate tissue, relieving blockage at the bladder opening. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Palese, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for men experiencing urinary issues due to bladder outlet obstruction, often caused by an enlarged prostate (Benign Prostatic Hyperplasia). Participants should have symptoms like difficulty urinating and will be assessed using the IPSS score. Specific eligibility details are not provided but typically would exclude those with certain health conditions or treatments that could interfere with the study.

Inclusion Criteria

Baseline peak urinary flow rate (Qmax) of less than 15 mL/s

My kidney function test shows creatinine less than 2 mg/dL.

I am a man aged 45-80 with urinary symptoms due to prostate enlargement.

Exclusion Criteria

BMI > 42

Known illicit substance abuse

Patients with latex allergies which would permit latex catheterization perioperatively as silicone catheterization is not recommended during HIFU treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo HIFU therapy for benign prostatic tissue ablation

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for adverse events and recovery, including catheterization and pain assessment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in IPSS, PSA levels, and sexual function

12 months

Multiple visits at 1 week, 1, 3, 6, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Focused Ultrasound (HIFU) Ablation

Trial Overview The trial tests High Intensity Focused Ultrasound (HIFU) as a treatment to remove benign prostatic tissue causing urinary problems. It measures changes in symptom scores, operation characteristics, pain levels post-operation, urine flow improvement, PSA levels, medication needs, prostate size and calcification, sexual function and reoperation rates within a year.

How Is the Trial Designed?

Group I: Participants with benign prostatic hyperplasia Experimental Treatment 1 Intervention

HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39184607/

A Systematic Review and Single-Arm Meta-Analysis on the ... HIFU presents significant clinical improvements in treating BPH, albeit with slow progression attributed to specific techniques and the ablative approach.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06601179

Study Details | NCT06601179 | Evaluating the Safety and ... The impact of the HIFU treatment on the urinary flow will be evaluated by measuring Q max 1 month, 3 months, 6 months, 12 months after treatment defined by: The ...

3. fusfoundation.org fusfoundation.org/posts/benign-prostatic-hyperplasia-focused-ultrasound-clinical-trial-launched/

Benign Prostatic Hyperplasia Focused Ultrasound Clinical ... Key Points. The new study is using EDAP's robotic focused ultrasound system to treat benign prostatic hyperplasia (BPH).

4. cureus.com cureus.com/articles/273702-a-systematic-review-and-single-arm-meta-analysis-on-the-efficacy-of-high-intensity-focused-ultrasound-for-benign-prostatic-hyperplasia-treatment-a-forgotten-option.pdf

A Systematic Review and Single-Arm Meta A Systematic Review and Single-Arm Meta-. Analysis on the Efficacy of High-Intensity,. Focused Ultrasound for Benign Prostatic. Hyperplasia ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429598001186

Clinical outcome of high-intensity focused ultrasound for ... Results. IPSS and QOL scores showed significant improvement after using both HIFU1 and HIFU2 at 3, 6, and 12 months, postoperatively (P < 0.0001 to < 0.01; ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8536134/

Treatment of benign prostatic hyperplasia with high ... Conclusions: Transrectal HIFU treatment of symptomatic BPH is safe, reduces symptoms significantly, and leads to a slight increase in uroflow. Publication types.