Robotic Surgery vs HIFU for Prostate Cancer

Overseen By Jihad Kaouk, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Pelvic surgery, Prostate treatment, Coagulopathy, others

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

Compensation: Varies

Number of Visits: 9

Duration: 1 day

276 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment High-intensity focused ultrasound (HIFU) for prostate cancer?

Research shows that High-Intensity Focused Ultrasound (HIFU) is a promising treatment for prostate cancer, offering precise targeting of cancerous tissue while sparing surrounding healthy tissue. Studies indicate it provides good cancer control with fewer side effects, such as better preservation of urinary and sexual functions. ^{1 2 3 4 5}

Is HIFU safe for treating prostate cancer?

High-intensity focused ultrasound (HIFU) is generally considered safe for treating localized prostate cancer, with studies showing it has a favorable side-effect profile and preserves quality of life. It is a minimally invasive treatment that targets and destroys cancerous tissue without damaging surrounding areas, allowing for repeated use if necessary. ^{2 6 7 8 9}

How does the treatment Robotic Surgery vs HIFU for Prostate Cancer differ from other treatments for this condition?

This treatment is unique because it combines robotic surgery and high-intensity focused ultrasound (HIFU), offering a non-invasive, precise, and bloodless option for prostate cancer. HIFU uses focused sound waves to destroy cancerous tissue without affecting surrounding areas, making it a minimally invasive alternative to traditional surgery or radiation. ^{1 4 5 10 11}

What is the purpose of this trial?

This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.

Research Team

Jihad Kaouk, MD

Principal Investigator

Glickman Urological & Kidney Institute: Professor of Urology

Eligibility Criteria

Men over 18 with low to intermediate risk localized prostate cancer, a life expectancy of more than 10 years, and specific MRI findings. They must have a Gleason score of 3+4 or less, PSA ≤10 ng/ml, and biopsy-confirmed stage T1a-T2c prostate cancer.

Inclusion Criteria

My prostate cancer is confirmed and in early stages with specific MRI and PSA levels.

Exclusion Criteria

I have a calcification in my prostate larger than 0.5 cc near the treatment area.

I do not have uncontrolled bleeding disorders or a latex allergy.

I have had treatments like radiotherapy or hormone therapy for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single-port transvesical partial prostatectomy or high-intensity focused ultrasound (HIFU) as a single treatment

1 day

1 visit (in-person)

Postoperative Follow-up

Participants have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks, and 4 weeks

4 weeks

1 visit (in-person), 3 calls (virtual)

Long-term Follow-up

Participants are monitored for recurrence and functional outcomes with office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years, and 3 years

3 years

7 visits (in-person)

Treatment Details

Interventions

• High-intensity focused ultrasound (HIFU)
• Transvesical Single Port Robotic Partial Prostatectomy

Trial Overview The trial compares single-port robotic partial prostatectomy (a minimally invasive surgery) with High-intensity focused ultrasound (HIFU), which uses sound waves to destroy cancer cells in patients with localized prostate cancer.

Participant Groups

Group I: Transvesical Single Port Robotic Partial Prostatectomy Active Control 1 Intervention

Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

Group II: High-intensity focused ultrasound (HIFU) Active Control 1 Intervention

Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

High-intensity focused ultrasound (HIFU) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as High-Intensity Focused Ultrasound for:

• Localized prostate cancer
• Low to intermediate risk prostate cancer

Approved in European Union as High-Intensity Focused Ultrasound for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Salvage treatment for recurrent prostate cancer

Approved in Canada as High-Intensity Focused Ultrasound for:

• Localized prostate cancer
• Low to intermediate risk prostate cancer

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

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]

In a study of 163 men with prostate cancer treated with high-intensity focused ultrasound (HIFU), 65% achieved biochemical disease-free status after a median follow-up of 72 months, indicating promising long-term efficacy.

The study found that a low postoperative PSA level (below 0.40 ng/ml) and careful patient selection, particularly for those with low- to intermediate-risk disease, are important predictors of long-term success in preventing disease recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound for the treatment of prostate cancer: A prospective trial with long-term follow-up. Mearini, L., D'Urso, L., Collura, D., et al.[2021]

High Intensity Focused Ultrasound (HIFU) is an effective method for ablating prostate cancer, focusing on destroying the tumor while preserving surrounding healthy tissue, which helps maintain urinary and sexual functions.

Clinical studies have shown that HIFU provides satisfactory cancer control with lower morbidity compared to traditional treatments, making it a promising option for patients with low to intermediate prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity focused ultrasound for Focal Therapy of prostate cancer. Sivaraman, A.[2017]

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]

High-Intensity Focused Ultrasound (HIFU) showed an overall success rate of 84% in treating prostate cancer among 25 patients, with particularly high success in low-risk patients (94.2%).

The procedure was safe, with no complications reported during or immediately after treatment, highlighting HIFU as a promising mini-invasive option for localized prostate cancer, although its effectiveness in high-risk patients requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Intensity Focused Ultrasound (HIFU): a useful alternative choice in prostate cancer treatment. Preliminary results. Maestroni, U., Ziveri, M., Azzolini, N., et al.[2019]

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]

In a study of 191 patients with localized prostate cancer treated with high-intensity focused ultrasound (HIFU), 81.7% of those with low-risk disease achieved durable cancer control, indicating HIFU is particularly effective for this group.

The study found that while HIFU showed decreasing efficacy in intermediate and high-risk patients, overall survival rates at 5 years were high (86.3% overall and 98.4% cancer-specific), suggesting it can be a viable treatment option, though higher-risk patients may require additional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single application of high-intensity focused ultrasound as a first-line therapy for clinically localized prostate cancer: 5-year outcomes. Pfeiffer, D., Berger, J., Gross, AJ.[2022]

High-intensity focused ultrasound (HIFU) is a promising focal therapy for localized prostate cancer, offering effective treatment with minimal side effects and preserving patients' quality of life and potency.

Three HIFU devices (Sonablate™, Ablatherm™, and FocalOne™) are currently approved for use, and while initial oncologic results are satisfactory, further follow-up is needed to confirm long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Focal Therapy with High-Intensity Focused Ultrasound in the Management of Clinically Localized Prostate Cancer. Kuru, TH., van Essen, J., Pfister, D., et al.[2015]

High-intensity focused ultrasound (HIFU) is a safe and effective noninvasive treatment for localized prostate cancer, achieving a 5-year biochemical disease-free rate of 67% among 132 patients.

The effectiveness of HIFU varies significantly based on pretreatment PSA levels, with a 5-year disease-free rate of 88% for PSA levels under 10 ng/ml, decreasing to only 13% for levels above 30.01 ng/ml.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High-intensity focused ultrasound for localized prostate cancer]. Uchida, T.[2011]

In a study of 569 men with nonmetastatic prostate cancer treated with whole-gland high-intensity focused ultrasound (HIFU), the 5-year failure-free survival rate was 70%, indicating effective disease control, especially among low-risk patients (87%).

HIFU treatment was associated with low rates of urinary incontinence (88% of patients remained pad-free) and similar rates of erectile dysfunction and need for further interventions compared to traditional treatments like surgery and radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort. Dickinson, L., Arya, M., Afzal, N., et al.[2022]

In a study of 30 men who underwent high intensity focused ultrasound (HIFU) for localized prostate cancer, over 75% of post-treatment biopsies showed the presence of adenocarcinoma in patients with rising PSA levels, indicating that HIFU may not completely eliminate cancer in some cases.

Stromal fibrosis was commonly observed in post-HIFU biopsy tissues, but this did not hinder pathologists' ability to detect and grade adenocarcinoma, suggesting that HIFU's tissue effects are manageable for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostatic needle biopsies following primary high intensity focused ultrasound (HIFU) therapy for prostatic adenocarcinoma: histopathological features in tumour and non-tumour tissue. Ryan, P., Finelli, A., Lawrentschuk, N., et al.[2012]

References

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

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High-intensity focused ultrasound for the treatment of prostate cancer: A prospective trial with long-term follow-up. [2021]

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High intensity focused ultrasound for Focal Therapy of prostate cancer. [2017]

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

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High Intensity Focused Ultrasound (HIFU): a useful alternative choice in prostate cancer treatment. Preliminary results. [2019]

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

7. England pubmed.ncbi.nlm.nih.gov

Single application of high-intensity focused ultrasound as a first-line therapy for clinically localized prostate cancer: 5-year outcomes. [2022]

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Role of Focal Therapy with High-Intensity Focused Ultrasound in the Management of Clinically Localized Prostate Cancer. [2015]

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[High-intensity focused ultrasound for localized prostate cancer]. [2011]

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Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort. [2022]

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Prostatic needle biopsies following primary high intensity focused ultrasound (HIFU) therapy for prostatic adenocarcinoma: histopathological features in tumour and non-tumour tissue. [2012]