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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called high intensity focused ultrasound (HIFU) to evaluate its effectiveness for men whose prostate cancer has returned after radiation. Researchers aim to determine if this treatment can effectively target and treat the cancer without further spread. They also seek to assess how this treatment impacts participants' quality of life. Men who have undergone radiation treatment for prostate cancer and are experiencing a recurrence in the same area might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that the Focal One high intensity focused ultrasound device is safe for treating prostate cancer?

Research shows that high-intensity focused ultrasound (HIFU) is generally well-tolerated by patients with prostate cancer. In past studies, HIFU demonstrated promising results in treating cancer without severe side effects. Reports indicate that patients treated with HIFU experience manageable side effects, with no significant risk of major complications or long-term problems. Most patients handle the treatment well, with any negative effects being mild and temporary.

The safety of HIFU is supported by findings that confirm its effectiveness for treating localized prostate cancer. Patients receiving this treatment have shown positive outcomes without needing more aggressive treatments. While every treatment carries risks, evidence so far suggests that HIFU is a safe option for many patients with localized prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about High Intensity Focused Ultrasound (HIFU) for prostate cancer because it offers a non-invasive alternative to traditional treatments like surgery and radiation. Unlike these standard options, which can have significant side effects, HIFU targets and destroys cancerous tissue using focused sound waves, potentially reducing damage to surrounding healthy tissue. This method may lead to fewer side effects and a quicker recovery time, making it an appealing option for patients and doctors alike.

What evidence suggests that this high intensity focused ultrasound device is effective for prostate cancer?

Research has shown that high intensity focused ultrasound (HIFU) effectively treats prostate cancer that hasn't spread. Studies have found that this treatment can target and destroy cancer cells in the prostate without causing the disease to spread. In one study, 85% of patients who received focal HIFU did not need further treatment after five years. Another study found that 7 out of 10 men had good results and maintained a good quality of life after HIFU treatment. This trial will evaluate the Focal One high intensity focused ultrasound device, suggesting that HIFU could be a promising option for patients with localized prostate cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Tarik Benidir, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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) 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]

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]

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]

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]

Citations

1. focalone.com focalone.com/clinical-information/

HIFU Clinical Information The ablation of prostate tissue with HIFU has shown reproducible results in treating clinically significant cancer and avoiding progression to radical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6156573/

A Multicentre Study of 5-year Outcomes Following Focal ... Focal HIFU therapy for patients with clinically significant prostate cancer that has not spread has a low probability of side effects and is effective at 5 yr.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456924002463

Prostate Cancer Survival Outcomes and Recurrence ... Our survival data after focal HIFU treatment for localized PC show favorable outcomes, with a retreatment-free survival rate of 85% at 5 yr for favorable ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7335960/

Survival and quality of life outcomes of high-intensity ... Whole-gland HIFU ablation was demonstrated to be an effective treatment of localized prostate cancer. In summary, 7 of 10 men treated with HIFU could expect ...

5. nature.com nature.com/articles/s41391-024-00921-0

Focal therapy using high-intensity focused ultrasound with ... Focal therapy using HIFU with intraoperative prostate compression would improve medium-term oncological outcomes without the risk of functional deterioration.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06402357

High Intensity Focused Ultrasound in Prostate Cancer Furthermore, HIFU has demonstrated favorable oncologic outcomes in well selected patients, including those with intermediate and high risk disease. In patients ...