MR-Guided Focal Therapy for Prostate Cancer

Overseen By Karen K Holcomb

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new method, Transurethral UltraSound Ablation (TULSA), guided by MRI scans, can effectively treat localized prostate cancer. TULSA uses heat to target and destroy cancerous areas in the prostate, potentially offering a less invasive treatment option. It suits individuals with prostate cancer visible on an MRI and suitable for heat-based treatment methods. Participants will undergo various screenings and follow-up visits to monitor the treatment's effectiveness. As an unphased trial, this study provides participants the opportunity to contribute to pioneering research in prostate cancer treatment.

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 method is safe for treating localized prostate cancer?

Research has shown that TULSA, or Transurethral Ultrasound Ablation, safely treats prostate cancer. Studies have found that it lowers PSA levels, indicators of prostate cancer, while preserving important bodily functions.

In one study, 22 men with localized prostate cancer received TULSA treatment, which proved safe and effective. Another report noted that most patients did not require further prostate cancer treatment after undergoing TULSA.

Overall, research suggests that TULSA is well-tolerated with few complications, making it a promising option for those considering treatment for localized prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TULSA-PRO for prostate cancer because it offers a minimally invasive approach that uses MRI-guided ultrasound to precisely target and ablate cancerous tissue. Unlike traditional treatments like surgery or radiation, which can affect a larger area and potentially lead to significant side effects, TULSA-PRO focuses only on the cancerous regions of the prostate. This precision aims to reduce the risk of side effects such as incontinence and erectile dysfunction, making it a promising option for patients seeking effective treatment with a quicker recovery time.

What evidence suggests that Transurethral UltraSound Ablation (TULSA) with MRI guidance is effective for treating localized prostate cancer?

Research has shown that TULSA-PRO, the treatment under study in this trial, is a promising option for prostate cancer. A review of studies found that it effectively lowers prostate-specific antigen (PSA) levels, indicators of prostate cancer, while maintaining function. In another study, 76% of patients had no detectable cancer in a follow-up test one year after treatment. Additionally, TULSA-PRO causes fewer erectile side effects compared to other treatments. These findings suggest that TULSA-PRO could be a safe and effective option for treating localized prostate cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Peter A Pinto, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9231661/

A Systematic Review - PMC Conclusion. TULSA is a safe and effective modality for prostate tissue ablation, demonstrating PSA reduction across PCa indications and functional preservation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10464407/

First experiences using transurethral ultrasound ablation ... In this mentioned study, clinically significant PCa was found in 10/29 patients (35%) and cancer of any stage was detected in 17/29 patients (59 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143924009414

158 real-world efficacy of mri-guided transurethral ... Among patients with minimum 12 months follow-up, 91% are pad-free, and 96% leak-free (EPIC). By 6 months, 21% reported erectile dysfunction, ongoing in 17% by ...

4. prostatelasercenter.com prostatelasercenter.com/blog/success-rate-tulsa-prostate-cancer-treatment/

TULSA Prostate Treatment Success Rate According to this data, erectile-related side effects with TULSA-PRO occur significantly less frequently than with the three other treatment ...

5. sirweb.org sirweb.org/for-press/new-treatment-option-for-prostate-cancer-shows-successful-outcomes/

New treatment option for prostate cancer shows successful ... Cancer was undetectable on follow up biopsy by 76% at one year after TULSA with a decrease in median prostate volume by 92% within one year and a decrease in ...

6. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109960.86805.2e.07

PD19-07 REAL-WORLD OUTCOMES AFTER MRI ... Primary endpoints were the rate of complications attributable to TULSA (safety), and the rate of freedom from additional PCa treatment (efficacy) ...

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

Prostate Cancer Salvage Magnetic Resonance Imaging ... The oncological outcomes are encouraging, with a 95% reduction in PSA levels at 12 mo, 89% of patients showing no cancer on biopsy in the targeted area, and 78% ...

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

Magnetic resonance imaging‐guided transurethral ultrasound ... This prospective early phase II study demonstrates that TULSA is a safe and effective treatment for BPO, offering significant improvements in ...