Image-Guided Ablation for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Acute UTI, Uncontrolled coagulopathies, others

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

Compensation: Varies

Number of Visits: 9

Duration: 1-2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating prostate cancer using a laser device guided by ultrasound, known as the Ultrasound Image-Guided Ablation Device. Researchers aim to determine if this method is more comfortable and effective than traditional MRI guidance. The focus is on treating cancer confined to the prostate. Men diagnosed with prostate cancer visible on an MRI, without metastasis, might be suitable candidates. The goal is to assess whether this approach can become a practical option for prostate cancer treatment. As an unphased trial, this study provides patients the opportunity to contribute to pioneering research that could lead to new treatment options.

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 prior data suggests that this ultrasound image-guided ablation device is safe for treating prostate cancer?

Research has shown that treatments like the one in this trial are generally safe. For example, a study on similar treatments found that high-intensity focused ultrasound (HIFU) for prostate cancer resulted in low complication rates, meaning patients experienced fewer issues with urinary and sexual functions. Another study on MRI-guided ultrasound treatment demonstrated that patients remained safe and maintained their quality of life for up to a year after treatment. These findings suggest that ultrasound-guided methods for treating prostate cancer are likely well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound image-guided ablation device for prostate cancer because it offers a more precise, minimally invasive treatment option compared to traditional surgery or radiation. Unlike conventional methods, which can affect the entire prostate and surrounding tissues, this technique targets only cancerous areas, potentially reducing side effects and preserving healthy tissue. Additionally, the use of real-time ultrasound guidance enhances accuracy, ensuring that the ablation is delivered exactly where needed.

What evidence suggests that this ultrasound image-guided ablation device is effective for prostate cancer?

Research has shown that ultrasound-guided treatment can effectively target prostate cancer. In this trial, participants will receive ultrasound image-guided focal ablation. Studies indicate that this method better preserves important functions, such as urinary control, compared to some traditional treatments like surgery or radiation. Focal therapy, which targets only the cancerous part of the prostate, provides good disease control while minimizing harm to healthy tissue. Early findings suggest that using ultrasound for real-time imaging during treatment is both practical and feasible. This approach aims to destroy cancerous tissue while reducing side effects. ^{4 6 7 8 9}

Who Is on the Research Team?

Peter A Pinto, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

This trial is for men 18+ with non-aggressive, localized prostate cancer that hasn't spread and can be seen on MRI. They must have had a recent MRI and biopsy at NIH, meet certain health guidelines (like ECOG status ≤2), and the tumor should be safely away from critical areas like the urethra.

Inclusion Criteria

My prostate cancer is in the early stages and not aggressive.

I understand this treatment is experimental and there are other standard options.

My tumor is located safely away from critical areas as per my doctor.

Exclusion Criteria

Inability to undergo a contrast-enhanced MRI per American College of Radiology and the Clinical Center, Department of Radiology guidelines

Patient unable to commit to follow-up

A serious acute or chronic illness that is determined by the PI to place the patient at unreasonable risk for anesthesia and the procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo ultrasound-guided focal thermal ablation of prostate cancer

1-2 days

1 visit (in-person)

Immediate Post-Treatment

Participants have a physical exam and PSA blood test the day after treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with 6 follow-up visits over 3 years

3 years

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Image-Guided Ablation Device

Trial Overview Researchers are testing a laser device guided by ultrasound to treat prostate cancer lesions. The goal is to see if this method is practical compared to using MRI guidance, focusing on comfort during treatment.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

ultrasound image-guided focal ablation

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Published Research Related to This Trial

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 prospective phase II trial involving 44 men with intermediate-risk prostate cancer, MRI-guided focal therapy using high-intensity focused ultrasound was found to be safe, with no major treatment-related adverse events reported.

At the 5-month follow-up, 93% of participants were free of clinically significant prostate cancer at the treatment site, indicating promising early oncologic outcomes, while functional outcomes related to erectile function and urinary symptoms remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. Ghai, S., Finelli, A., Corr, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11678519/

High-Intensity Focus Ultrasound Ablation in Prostate Cancer The literature highlights that HIFU may offer superior functional outcomes, particularly in continence recovery, compared to RP and radiation therapy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2287888225000637

Review article Advances in focal therapy for prostate cancer Focal therapy (FT) has emerged as a promising treatment option for localized prostate cancer (PCa), offering oncologic control with reduced ...

3. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.231473

Final Results from a 2-year Phase II Clinical Trial | Radiology In this phase II trial of 44 men with clinically significant prostate cancer (csPCa) treated with focal therapy with MRI-guided focused ...

4. nature.com nature.com/articles/s41391-024-00907-y

Identifying the best candidate for focal therapy This study aims to review the most recent evidence concerning the optimal approach to patient selection for FT in PCa.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02759744?term=visualase&recrs=abdf&cond=prostate+cancer&draw=2&rank=3

Fusion Guided Focal Laser Ablation of Prostate Cancer Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal thermal ablation of low to intermediate risk focal prostate tumors.

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

Survival and quality of life outcomes of high-intensity ... In comparison with a previously published Australian series on HIFU ablation for prostate cancer, our results showed significantly better survival and QoL ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S266616832401423X

Prostate Cancer Salvage Magnetic Resonance Imaging ... This phase 2 study evaluates the outcomes of salvage magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (sTULSA).

8. goldjournal.net goldjournal.net/article/S0090-4295(23)00071-7/fulltext

Real-World Comparative Safety and Effectiveness of ... Both IRE and HIFU were found to produce favorable effectiveness outcomes and have low complication rates while minimally impacting patient urinary and erectile ...

9. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.16795

Magnetic resonance imaging‐guided transurethral ultrasound ... Safety, efficacy and quality of life outcomes of MRI-guided transurethral ultrasound ablation for localized prostate cancer: 12-month outcomes.