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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for prostate cancer: a new robotic surgery and high-intensity focused ultrasound (HIFU). It aims to determine which treatment works better for individuals with low to intermediate risk localized prostate cancer. Participants will undergo either a one-time robotic surgery or a HIFU session, with regular follow-ups to monitor progress. This trial suits those who have had a biopsy confirming prostate cancer and have not undergone extensive treatments or surgeries in the pelvic area. The goal is to identify the best treatment option with fewer side effects and better outcomes. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future prostate cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both High-intensity focused ultrasound (HIFU) and single-port robotic partial prostatectomy are generally well-tolerated treatments for prostate cancer.

For single-port robotic partial prostatectomy, studies indicate it is a safe option for patients with localized prostate cancer. This method improves surgical outcomes and safety compared to older techniques. Patients often recover faster and experience fewer side effects.

Similarly, research on HIFU suggests it is also a safe choice. It targets cancer cells without harming nearby tissue. Patients treated with HIFU often achieve good results without major side effects, maintaining their quality of life.

Both treatments offer distinct benefits and risks, but they are generally safe for treating localized prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer innovative approaches that could improve patient outcomes. Transvesical Single Port Robotic Partial Prostatectomy uses a minimally invasive robotic technique that may reduce recovery time and surgical trauma compared to traditional open surgery. High-intensity focused ultrasound (HIFU) provides a non-invasive option that precisely targets and destroys cancerous tissue without the need for incisions, potentially leading to fewer side effects and a quicker return to daily activities. Both treatments aim to enhance precision and reduce the impact on surrounding healthy tissue, which is a significant advancement over standard treatments like traditional surgery and radiation therapy.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare two treatments for localized prostate cancer: the single-port robotic transvesical partial prostatectomy and high-intensity focused ultrasound (HIFU). Research has shown that the single-port robotic transvesical partial prostatectomy is promising, linked to quicker recovery times and good early recovery rates. This treatment uses robotic technology for precise, targeted surgery, making it effective for patients with low to intermediate-risk prostate cancer.

Similarly, studies have found that HIFU effectively treats prostate cancer. About 70% of men treated with HIFU experienced successful outcomes without needing additional treatment over seven years. Additionally, HIFU is associated with fewer side effects and better recovery times, offering a good balance between effectiveness and quality of life. ^{3 6 7 8 9}

Who Is on the Research Team?

Jihad Kaouk, MD

Principal Investigator

Glickman Urological & Kidney Institute: Professor of Urology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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) 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]

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]

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) 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]

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]

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]

Citations

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

Survival and quality of life outcomes of high-intensity ... In summary, 7 of 10 men treated with HIFU could expect successful treatment (no salvage therapy, metastatic disease, or cancer-specific mortality) at 7 years.

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37422679/

Prostate cancer outcomes following whole-gland and focal ... The 5-year FFS for ISUP Grade Groups 1-5 was 82.9%, 76.6%, 72.2%, 52.3% and 30.8%, respectively (P < 0.001). Freedom from repeat HIFU was 79.1% (95% CI 75.7%- ...

4. news.keckmedicine.org news.keckmedicine.org/hifu-can-help-maintain-prostate-cancer-patients-quality-of-life/

HIFU effective for treating prostate cancer New study suggests that high-intensity focused ultrasound ablation is effective against prostate cancer with decreased side effects and improved recovery time.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.362

Determining optimal patient selection for high-intensity ... Conclusions: Treatment failure rate was 16%, and in-field and overall recurrence rates on biopsy one year after HIFU were 42% and 50%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8692047/

High-Intensity Focused Ultrasound (HIFU) Focal Therapy ... The study aimed at investigating the outcome of prostate HIFU focal therapy using the MRI-US fusion platform for treatment localization and delivery.

7. 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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06402357

High Intensity Focused Ultrasound in Prostate Cancer This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer.

9. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/impact-reports/2020/research-highlights/positive-results-for-new-treatment-strategy-for-localized-prostate-cancer

Positive Results for New Treatment Strategy for Localized ... A Sylvester research team has found that focal high intensity focused ultrasound (HIFU) is an effective strategy for treating localized prostate cancer ...