MR-Guided Focal Therapy for Prostate Cancer

Overseen By Jill M Harper, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Uncontrolled coagulopathies, Congestive heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

21 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods. Objective: To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer. Eligibility: English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation. Design: Participants will be screened with the following: * Medical history * Physical exam * Digital rectal exam * Blood and urine tests * Electrocardiogram * Tumor biopsy * Questionnaire to assess urinary tract symptoms * MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner. Participants may also be screened with the following: * Echocardiogram * Chest x-ray * Bone scan * Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine * MRI of the brain * Transrectal ultrasound * Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body. Some screening tests will be repeated during the study. Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum. Participants will use a urethral catheter for 1-7 days. Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.

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 TULSA-PRO for prostate cancer?

Research shows that TULSA-PRO, a treatment using ultrasound guided by MRI, was effective in reducing prostate cancer in most patients, with 8 out of 9 showing significant improvement and no major side effects. This suggests it could be a safe and effective option for treating localized prostate cancer. ^{1 2 3 4 5}

Is MR-Guided Focal Therapy for Prostate Cancer safe for humans?

Research shows that MR-Guided Focal Therapy, also known as TULSA, appears to be safe for treating prostate cancer, with no major urinary or gastrointestinal side effects and no changes in erectile firmness observed in patients. ^{1 3 5 6 7}

How is the TULSA-PRO treatment different from other prostate cancer treatments?

TULSA-PRO is unique because it uses MRI guidance to precisely target and heat prostate tissue, allowing for focused treatment of cancerous areas while minimizing damage to surrounding healthy tissue. This minimally invasive approach aims to maintain quality of life by reducing side effects commonly associated with traditional treatments like surgery and radiotherapy. ^{1 2 4 5 8}

Research Team

Peter A Pinto, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for English-speaking adults aged 18+ with localized prostate cancer visible on MRI and treatable by thermal ablation. They must have a Gleason Score <= 7, PSA < 20 ng/ml, adequate organ function, and be able to consent. Exclusions include inability to undergo MRI, severe urinary symptoms (IPSS > 20), multiple cancer lesions on MRI, or serious illnesses that could affect study participation.

Inclusion Criteria

Platelets >= 50,000/mcL

Subjects must be able to understand and willing to sign a written informed consent document.

My organs and bone marrow are functioning well.

Exclusion Criteria

The area targeted for treatment in my body is larger than 100 ml.

The participant with the inability to follow up

My MRI shows 3 or more lesions positive for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple visits for various tests

Treatment

Participants undergo the TULSA procedure with MRI guidance for focal prostate cancer ablation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Follow-up visits at 3, 6, 12, 18, 24, and 36 months

Treatment Details

Interventions

• TULSA-PRO

Trial Overview The study tests Transurethral UltraSound Ablation (TULSA) guided by MRI for treating localized prostate cancer. Participants will undergo TULSA where heat destroys targeted cancer areas in the prostate using an ultrasound applicator controlled by a robotic arm while being monitored via MRI.

Participant Groups

Group I: 1/Arm 1 Experimental Treatment 1 Intervention

Ultrasound ablation of focal prostate cancer

TULSA-PRO is already approved in United States for the following indications:

Approved in United States as TULSA-PRO for:

• Localized prostate cancer
• Benign prostatic hyperplasia (BPH)
• Enlarged prostate

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 9 men with low-to-intermediate-risk prostate cancer, the TULSA procedure achieved over 75% reduction in cancer in 8 out of 9 patients, indicating strong efficacy.

The procedure was found to be safe, with no major urinary or gastrointestinal side effects and no changes in erectile firmness reported after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial. Sundaram, KM., Staruch, R., Burtnyk, M., et al.[2020]

In a study of 52 men with localized prostate cancer, MR-guided transurethral ultrasound ablation (TULSA) demonstrated an 88% early treatment success rate, defined by negative MRI results and no PSA recurrence, indicating its efficacy in treating prostate cancer.

TULSA was also effective for patients with concurrent benign prostate hyperplasia (BPH), with 83% reporting symptom improvement, while maintaining a favorable safety profile with only two Grade IIIa adverse events and no bowel complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single center retrospective analysis of fifty-two prostate cancer patients with customized MR-guided transurethral ultrasound ablation (TULSA). Lumiani, A., Samun, D., Sroka, R., et al.[2022]

Transurethral ultrasound ablation (TULSA) for localized prostate cancer was performed safely in 22 men, with no major adverse events reported and no significant changes in urinary or bowel function after 12 months.

While TULSA effectively reduced PSA levels significantly (from 6.8 to 2.1 ng/ml), 23% of patients experienced cancer recurrence, and erectile function was notably impaired in the months following treatment, highlighting the need for thorough patient counseling regarding potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experiences using transurethral ultrasound ablation (TULSA) as a promising focal approach to treat localized prostate cancer: a monocentric study. Peters, I., Hensen, B., Glandorf, J., et al.[2023]

MRI-guided transurethral ultrasound ablation (MRI-TULSA) is a safe and feasible method for whole-gland prostate ablation in localized prostate cancer, with a low incidence of serious adverse events and no rectal injuries reported among the 30 patients studied over 12 months.

The treatment showed promising efficacy, with an 87% reduction in PSA levels at one month and a significant decrease in cancer length in biopsies, indicating potential for effective disease control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Chin, JL., Billia, M., Relle, J., et al.[2018]

In a study involving six men with localized prostate cancer, MRI-guided transurethral ultrasound ablation (TULSA) showed significant changes in MRI findings, including increased prostate and non-perfused volumes one and three weeks post-treatment.

The optimal timing for follow-up MRI after TULSA is suggested to be three weeks, as this allows for the reduction of post-procedural edema and maturation of non-perfused volume, while diffusion-weighted imaging provided limited additional diagnostic value during this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and subacute prostate MRI findings after MRI-guided transurethral ultrasound ablation of prostate cancer. Mäkelä, P., Anttinen, M., Suomi, V., et al.[2021]

In a phase I study involving 10 men, MRI-guided transurethral ultrasound ablation (TULSA) demonstrated safety with no severe adverse events and significant improvements in urinary symptoms, with an 82% reduction in the International Prostate Symptom Score (IPSS) after 12 months.

TULSA also led to a 101% increase in maximum urinary flow rate and a 33% reduction in prostate volume, while maintaining sexual and bowel functions, indicating its efficacy as a treatment for benign prostatic obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study. Viitala, A., Anttinen, M., Wright, C., et al.[2022]

The MR-Guided Transurethral Ultrasound Ablation (TULSA) procedure showed acceptable safety and functional outcomes in men with localized prostate cancer, with no significant differences in adverse events or urinary symptoms between the Phase I and Pivotal trials after 6 months.

Intensified treatment parameters in the Pivotal trial increased the ablation coverage from 90% to 98% of the prostate tissue without compromising safety or functional outcomes, suggesting that higher intensity treatments can be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: single-center evaluation of 6-month treatment safety and functional outcomes of intensified treatment parameters. Hatiboglu, G., Popeneciu, V., Bonekamp, D., et al.[2021]

Targeted image-guided therapies like Transurethral Ultrasound Ablation (TULSA) and MRI-guided High-Intensity Focused Ultrasound (HIFU) offer effective treatment for localized prostate cancer while minimizing damage to surrounding tissues, thus preserving genitourinary function.

Studies, including a large multicenter trial, have shown that TULSA has a favorable safety profile and low impact on quality of life, making it a promising alternative to traditional radical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving imaging methods of prostate cancer and the emergence of magnetic resonance imaging guided ablation techniques. Anttinen, M., Blanco Sequeiros, R., Boström, PJ., et al.[2022]

References

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

MR Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial. [2020]

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

Single center retrospective analysis of fifty-two prostate cancer patients with customized MR-guided transurethral ultrasound ablation (TULSA). [2022]

3. England pubmed.ncbi.nlm.nih.gov

First experiences using transurethral ultrasound ablation (TULSA) as a promising focal approach to treat localized prostate cancer: a monocentric study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. [2018]

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

Acute and subacute prostate MRI findings after MRI-guided transurethral ultrasound ablation of prostate cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: single-center evaluation of 6-month treatment safety and functional outcomes of intensified treatment parameters. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evolving imaging methods of prostate cancer and the emergence of magnetic resonance imaging guided ablation techniques. [2022]