HIFEM Technology for Post-Prostate Surgery

Overseen By Mitchell R Humphreys, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Muscle relaxants

Disqualifiers: Neurologic disease, Atonic bladder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 3 weeks

2100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes participants who are using medications that cause muscle relaxation or inhibition, so you may need to stop taking such medications to participate.

What data supports the effectiveness of the treatment HIFEM Technology for post-prostate surgery?

High-intensity focused ultrasound (HIFU), a similar technology, is considered a promising treatment for prostate cancer, offering comparable outcomes to other treatments with potentially fewer side effects, especially in cases of cancer recurrence after radiation therapy. ^{1 2 3 4 5}

How is HIFEM Technology different from other treatments for post-prostate surgery?

HIFEM Technology is unique because it uses high-intensity focused electromagnetic fields to stimulate muscle contractions, which is different from traditional treatments that may involve surgery or medication. This non-invasive approach can help improve muscle strength and function without the need for incisions or drugs. ^{4 6 7 8 9}

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).

Research Team

Mitchell R Humphreys, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men recovering from radical prostatectomy or Holmium laser prostate surgery who are looking to improve urinary control and quality of life. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to complete the questionnaires and visits required.

I am male.

I have had surgery to remove my prostate.

Exclusion Criteria

I have had surgery on my urinary or genital organs before.

Documented urine leak

I am not male.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2, 30-minute sessions weekly for 3 weeks using the Emsella device or a sham comparator device

3 weeks

6 visits (in-person)

Wash-out

A 1-week wash-out period where no treatment is administered

1 week

Optional Extension

Participants experiencing urinary leakage may continue or cross-over to active treatment for an additional 3 weeks

3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

Treatment Details

Interventions

• HIFEM Technology

Trial Overview The study tests High-Intensity Focused Electromagnetic (HIFEM) technology, using the EMSELLA® device, against a sham comparator to see if it speeds up recovery of urinary function post-surgery.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects randomized to the treatment group will receive 2, 30-minute sessions, weekly for 3 weeks using the Emsella device. After a 1 week wash-out period, subjects still experiencing urinary leakage will have the option to continue treatment for 3 additional weeks.

Group II: Placebo Group Placebo Group 1 Intervention

Subjects randomized to the placebo group will receive 2, 30-minute sessions, weekly for 3 weeks using a sham comparator device. After a 1 week wash-out period, subjects in the placebo group who are experiencing urinary leakage will be offered the opportunity to cross-over to an active treatment group for an additional 3 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

High Intensity Focused Ultrasound (HIFU) and brachytherapy both show safety in treating localized prostate cancer, with no significant differences in long-term cancer-specific survival rates, based on a study comparing matched patient groups.

However, brachytherapy resulted in better outcomes regarding urinary symptoms and biochemical recurrence-free survival, indicating it may be a more effective option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Intensity Focused Ultrasound versus Brachytherapy for the Treatment of Localized Prostate Cancer: A Matched-Pair Analysis. Aoun, F., Limani, K., Peltier, A., et al.[2020]

Contrast-enhanced ultrasound (CEUS) is a valuable tool for assessing treatment effects immediately after focal high intensity focused ultrasound (HIFU) for localized prostate cancer, showing a significant agreement with early multiparametric MRI (mpMRI) results.

In this study of 32 men, CEUS guided further ablation in 39% of cases and demonstrated a higher negative predictive value compared to mpMRI, suggesting it may enhance the efficacy of HIFU in ruling out clinically significant cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of intraoperative contrast-enhanced ultrasound in detecting residual disease after focal HIFU for localized prostate cancer. Bacchetta, F., Martins, M., Regusci, S., et al.[2021]

High intensity focused ultrasound (HIFU) can be affected by the presence of fiducial markers implanted during external beam radiation therapy, leading to decreased focal intensity and altered treatment delivery.

Simulations showed that markers positioned within 5 mm of the HIFU focus significantly distort the ultrasound beam, potentially resulting in areas of undertreatment and overtreatment, indicating a need for reevaluation of marker placement protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beam distortion due to gold fiducial markers during salvage high-intensity focused ultrasound in the prostate. Georgiou, PS., Jaros, J., Payne, H., et al.[2022]

Transrectal high-intensity focused ultrasound (HIFU) is a safe and minimally invasive treatment for elderly men with prostate cancer, with a significant reduction in major adverse events over time, such as rectal mucosa burns decreasing from 15% to 0%.

The treatment showed a notable decrease in urinary tract infections, from 58% initially to only 8% in later treatments, indicating improved safety and efficacy in managing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound: complications and adverse events. Thüroff, S., Chaussy, C.[2004]

High-intensity focused ultrasound (HIFU) is emerging as a promising alternative therapy for organ-confined prostate cancer and can also be used for local recurrence after radiation therapy.

HIFU shows comparable oncological outcomes to established salvage treatments for radiation-recurrent prostate cancer, with the potential for fewer side effects, making it a viable option for low-to-intermediate-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current role of high-intensity focused ultrasound for the management of radiation-recurrent prostate cancer. Sountoulides, P., Theodosiou, A., Finazzi-Agró, E.[2017]

High-Intensity Focused Ultrasound (HIFU) has been explored for treating prostate cancer, but the evidence is limited to case series with no randomized studies, and follow-up durations are generally short, averaging less than 2 years.

The treatment has significant toxicity risks, including high rates of impotence (44%-61%) and varying rates of incontinence (0%-14%), leading to the conclusion that HIFU should only be used in research settings until more robust efficacy data is available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology review: high-intensity focused ultrasound for prostate cancer. Pickles, T., Goldenberg, L., Steinhoff, G.[2005]

Robotic high intensity focused ultrasound (HIFU) is a non-invasive and precise treatment for prostate cancer, offering a bloodless alternative to traditional surgical methods.

Since its introduction in the 1990s, HIFU has become a widely used therapy for localized prostate cancer, often combined with other procedures to enhance effectiveness and minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transrectal high-intensity focused ultrasound for local treatment of prostate cancer: current role. Chaussy, CG., Thüroff, S.[2017]

High-intensity focused ultrasound (HIFU) is a safe and effective minimally invasive treatment for localized prostate cancer, achieving an 84.2% biochemical success rate in low and intermediate-risk patients after a mean follow-up of 67.9 months.

While HIFU shows promise, especially for low and intermediate-risk patients, its effectiveness decreases in high-risk patients, with only a 43.1% success rate, indicating that it may not be suitable for all prostate cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound (HIFU) in prostate cancer: a single centre experience in patients with low, intermediate or high-risk of progression. Callea, A., Piccinni, R., Zizzi, V., et al.[2016]

High-intensity focused ultrasound (HIFU) shows promising efficacy in treating localized and locally advanced prostate cancer, with biochemical disease-free survival rates ranging from 78% to 84% at 1 year and 45% to 84% at 5 years across 20 studies involving 3018 patients.

Despite its potential, the overall quality of evidence for HIFU's efficacy and safety is considered very low due to the lack of controlled study designs, indicating a need for further research to validate its effectiveness and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. Warmuth, M., Johansson, T., Mad, P.[2022]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

High Intensity Focused Ultrasound versus Brachytherapy for the Treatment of Localized Prostate Cancer: A Matched-Pair Analysis. [2020]

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

The utility of intraoperative contrast-enhanced ultrasound in detecting residual disease after focal HIFU for localized prostate cancer. [2021]

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

Beam distortion due to gold fiducial markers during salvage high-intensity focused ultrasound in the prostate. [2022]

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

High-intensity focused ultrasound: complications and adverse events. [2004]

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

The current role of high-intensity focused ultrasound for the management of radiation-recurrent prostate cancer. [2017]

6. Canada pubmed.ncbi.nlm.nih.gov

Technology review: high-intensity focused ultrasound for prostate cancer. [2005]

7. Spain pubmed.ncbi.nlm.nih.gov

Transrectal high-intensity focused ultrasound for local treatment of prostate cancer: current role. [2017]

8. Italy pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound (HIFU) in prostate cancer: a single centre experience in patients with low, intermediate or high-risk of progression. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. [2022]