High Intensity Focused Ultrasound for Prostate Cancer

Overseen By Priya Gurjar

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Hormone therapy

Disqualifiers: Inflammatory bowel disease, Metastatic, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had hormone therapy within 6 months before the screening period.

What data supports the effectiveness of the treatment Focal One high intensity focused ultrasound device for prostate cancer?

Research shows that high intensity focused ultrasound (HIFU) is a promising treatment for prostate cancer, with studies reporting positive early outcomes and manageable side effects. The Focal One device, specifically, has been used successfully in initial experiences to treat prostate cancer, indicating its potential effectiveness. ^{1 2 3 4 5}

Is high intensity focused ultrasound safe for treating prostate cancer?

High intensity focused ultrasound (HIFU) has been evaluated for safety in treating prostate cancer, with studies reporting on its safety outcomes. The FDA has allowed the marketing of HIFU devices for prostate tissue ablation, indicating a level of safety acceptance, although initial rejections were due to insufficient data on effectiveness rather than safety. ^{1 2 4 6 7}

How is the Focal One high intensity focused ultrasound treatment different from other prostate cancer treatments?

The Focal One high intensity focused ultrasound treatment is unique because it is a minimally invasive procedure that uses focused sound waves to target and destroy prostate cancer cells, offering promising outcomes with fewer side effects compared to traditional treatments like surgery or radiation. ^{1 2 3 5 8}

Research Team

Tarik Benidir, MD

Principal Investigator

University of Florida

Eligibility Criteria

This clinical trial is for individuals with localized prostate cancer that has come back after radiation therapy. Participants should be in good health otherwise and have a life expectancy of at least 10 years to see the long-term effects of the treatment.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

PSMA PET negative for metastatic disease (within 3 months of the biopsy)

My other prostate side has low-grade cancer.

Exclusion Criteria

My cancer has spread beyond its original location.

Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness

I have had urethral strictures in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focal high intensity focused ultrasound (HIFU) therapy for localized radiorecurrent prostate cancer

12 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety, effectiveness, and quality of life changes after HIFU treatment

12 months

Periodic visits for follow-up assessments

Long-term follow-up

Participants are monitored for long-term outcomes such as time to whole gland or systemic therapy and androgen deprivation therapy onset

3 years

Treatment Details

Interventions

• Focal One high intensity focused ultrasound device

Trial Overview The study is testing a device called Focal One which uses high intensity focused ultrasound (HIFU) to treat areas in the prostate affected by cancer. It aims to evaluate how effective this treatment is and its impact on patients' quality of life.

Participant Groups

Group I: High Intensity Focused Ultrasound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

EDAP-TMS Focal One

Collaborator

Trials

1

Recruited

30+

Findings from Research

Focal high intensity focused ultrasound (HIFU) is a safe and effective treatment for localized prostate cancer, with 83% of patients showing negative follow-up biopsies after treatment, indicating good oncologic control.

The treatment resulted in minimal complications, with only 5 major complications reported, and urinary and sexual functions returning to baseline levels within 3-6 months and 12 months, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of Focal High Intensity Focused Ultrasound for Localized Prostate Cancer. Nahar, B., Bhat, A., Reis, IM., et al.[2020]

High-intensity focused ultrasound (HIFU) using the Focal-One® device for localized prostate cancer treatment showed a median PSA reduction of 54% with a low complication rate of 15%, all classified as Clavien 2, indicating manageable issues.

At a median follow-up of 3 months, all patients maintained urinary continence, and 83% of those who were potent before treatment preserved their sexual function, highlighting the procedure's efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity focused ultrasound with Focal-One® device: Prostate-specific antigen impact and morbidity evaluation during the initial experience. Perez-Reggeti, JI., Sanchez-Salas, R., Sivaraman, A., et al.[2017]

High intensity focused ultrasound (HIFU) using the Sonablate 500 device showed promising results in treating prostate cancer, with 71.9% of patients having no biochemical evidence of disease after a median follow-up of 23.8 months.

The treatment led to a significant decrease in prostate specific antigen (PSA) levels, with a median nadir of 0.15 ng/ml, and a 66.1% negative biopsy rate at 6 months, indicating effective cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visually directed transrectal high intensity focused ultrasound for the treatment of prostate cancer: a preliminary report on the Italian experience. Mearini, L., D'Urso, L., Collura, D., et al.[2008]

High-intensity focused ultrasound (HIFU) is an effective short-term treatment for localized prostate cancer, significantly reducing PSA levels in patients after a median follow-up of 27.5 months.

The treatment has a low complication rate of 19.3%, although it did lead to a significant decrease in sexual function as measured by the IIEF questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-Up of Men Who Have Undergone Focal Therapy for Prostate Cancer with HIFU-A Real-World Experience. Mala, KS., Plage, H., Mödl, L., et al.[2023]

High intensity focused ultrasound (HIFU) is increasingly used in Europe for treating both primary and relapsed prostate cancer, showing promising results in local tumor destruction for low and medium risk localized cases.

However, there is a lack of randomized controlled trials comparing HIFU to conventional therapies, and inconsistencies in defining disease-free survival make it challenging to draw definitive conclusions about its long-term efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current state of high intensity focused ultrasound (HIFU) as treatment of prostatic carcinoma]. Lledó García, E., Jara Rascón, J., Herranz Amo, F., et al.[2019]

There is currently no robust data on the long-term effectiveness of high intensity focused ultrasound (HIFU) for treating localized prostate cancer in the United States, which poses challenges for clinical decision-making.

Patient preference data regarding the safety and effectiveness of HIFU treatment for prostate cancer is lacking, highlighting the need for future studies to better inform patients and regulators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Ablation Using High Intensity Focused Ultrasound: A Literature Review of the Potential Role for Patient Preference Information. Babalola, O., Lee, TJ., Viviano, CJ.[2019]

In a study of 81 men with radiorecurrent prostate cancer, salvage high intensity focused ultrasound (HIFU) showed a 35% rate of residual disease at 6 months, indicating that while some patients may still have cancer, the treatment is a viable option.

The 5-year overall survival rate was 88% and cancer-specific survival rate was 94.4%, suggesting that HIFU is effective in managing prostate cancer recurrence, with acceptable rates of complications such as rectal fistulization and severe incontinence at 3.7% each.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological, Oncologic and Functional Outcomes of a Prospective Registry of Salvage High Intensity Focused Ultrasound Ablation for Radiorecurrent Prostate Cancer. Siddiqui, KM., Billia, M., Arifin, A., et al.[2019]

In a study of 15 men who underwent salvage radical prostatectomy after failed high intensity focused ultrasound (HIFU) treatment for prostate cancer, the procedure was feasible but associated with higher morbidity compared to primary surgery, including one case of rectal injury.

Despite concerning pathology results showing a significant number of patients with advanced disease (pT3) and positive margins, early follow-up indicated that 14 out of 15 patients had unrecordable prostate-specific antigen levels post-surgery, suggesting acceptable oncologic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage radical prostatectomy following primary high intensity focused ultrasound for treatment of prostate cancer. Lawrentschuk, N., Finelli, A., Van der Kwast, TH., et al.[2011]

References

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

Prospective Evaluation of Focal High Intensity Focused Ultrasound for Localized Prostate Cancer. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

High intensity focused ultrasound with Focal-One® device: Prostate-specific antigen impact and morbidity evaluation during the initial experience. [2017]

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

Visually directed transrectal high intensity focused ultrasound for the treatment of prostate cancer: a preliminary report on the Italian experience. [2008]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Follow-Up of Men Who Have Undergone Focal Therapy for Prostate Cancer with HIFU-A Real-World Experience. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

[Current state of high intensity focused ultrasound (HIFU) as treatment of prostatic carcinoma]. [2019]

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

Prostate Ablation Using High Intensity Focused Ultrasound: A Literature Review of the Potential Role for Patient Preference Information. [2019]

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

Pathological, Oncologic and Functional Outcomes of a Prospective Registry of Salvage High Intensity Focused Ultrasound Ablation for Radiorecurrent Prostate Cancer. [2019]

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

Salvage radical prostatectomy following primary high intensity focused ultrasound for treatment of prostate cancer. [2011]