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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI). Objectives: To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment. Eligibility: Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body. Design: Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum. Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor. The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied. The next day, participants will have a physical exam and a PSA blood test. Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.

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 Ultrasound Image-Guided Ablation Device for prostate cancer?

Research on MRI-guided focused ultrasound ablation for prostate cancer shows that it is safe and effective, with 93% of participants being free of significant cancer at the treatment site after 5 months. This suggests that ultrasound-guided ablation can be a promising treatment for prostate cancer. ^{1 2 3 4 5}

Is image-guided ablation for prostate cancer safe?

Research shows that MRI-guided focused ultrasound ablation for prostate cancer is generally safe, with no major treatment-related adverse events reported in a study of 44 men. This suggests that the procedure is well-tolerated in humans. ^{3 5 6 7 8}

How is the Ultrasound Image-Guided Ablation Device treatment for prostate cancer different from other treatments?

The Ultrasound Image-Guided Ablation Device is unique because it uses high-intensity focused ultrasound (HIFU) to treat prostate cancer without direct instrumentation or ionizing radiation, offering a less-invasive alternative to standard therapies. ^{1 9 10 11 12}

Research Team

Bradford J Wood, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Ultrasound-based guidance of intensity-modulated radiation therapy. [2006]

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

Three-dimensional real-time magnetic resonance-guided interstitial prostate brachytherapy optimizes radiation dose distribution resulting in a favorable acute side effect profile in patients with clinically localized prostate cancer. [2006]

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

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. [2021]

4. France pubmed.ncbi.nlm.nih.gov

[Implementation of transabdominal ultrasound image guided conformal intensity modulated radiotherapy]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of MRI-guided transurethral ultrasound ablation for radiorecurrent prostate cancer in the presence of gold fiducial markers. [2023]

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

Outcome and safety of transrectal US-guided percutaneous cryotherapy for localized prostate cancer. [2019]

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

Technique of outpatient placement of intraprostatic fiducial markers before external beam radiotherapy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided focused ultrasound robotic system for transrectal prostate cancer therapy. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Sonablate-500: transrectal high-intensity focused ultrasound for the treatment of prostate cancer. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Single session of high-intensity focused ultrasound for localized prostate cancer: treatment outcomes and potential effect as a primary therapy. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The clinical applications of high intensity focused ultrasound in the prostate. [2019]