IRE + MRgRT for Prostate Cancer

(RTIRE Trial)

Overseen By Holly Kuczynski

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Metastatic cancer, Inflammatory bowel disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-site trial for 42 subjects with intermediate risk prostate cancer who undergo Irreversible Electroporation (IRE) followed by Magnetic Resonance guided Radiotherapy MRgRT. The investigators hypothesize that the combined therapy will feasible and be safe to perform with low morbidity. Ultimately, RTIRE may provide optimal treatment for intermediate risk prostate cancer patients.

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 this treatment for prostate cancer?

Research shows that irreversible electroporation (IRE) is promising for treating localized prostate cancer, as it effectively targets cancer cells while sparing surrounding healthy tissues. Imaging studies, like MRI and ultrasound, help assess the treatment's success and guide therapy planning. ^{1 2 3 4 5}

Is the combination of Irreversible Electroporation (IRE) and Magnetic Resonance guided Radiotherapy (MRgRT) safe for treating prostate cancer?

Irreversible Electroporation (IRE) has been studied for prostate cancer and is generally considered safe, with low rates of serious side effects like urethral stricture. Most men maintained their urinary and sexual functions after treatment, and the procedure is known to preserve important structures like nerves and blood vessels. ^{1 2 4 6 7}

How is the IRE + MRgRT treatment for prostate cancer different from other treatments?

The IRE + MRgRT treatment for prostate cancer is unique because it combines irreversible electroporation (IRE), which uses electric pulses to destroy cancer cells without heat, with magnetic resonance-guided radiotherapy (MRgRT), which allows precise targeting of radiation. This combination aims to effectively treat cancer while minimizing damage to surrounding healthy tissues. ^{1 2 3 6 8}

Research Team

Timothy McClure, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Men over 18 with intermediate risk prostate cancer, specifically grade group 2 or 3 as seen in MRI. They must be able to undergo IRE and MRgRT treatments, have a prostate gland size under 80 cc, an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity), and agree to follow-up biopsies. Excluded are those with metastatic cancer, prior pelvic radiotherapy or focal therapy, inflammatory bowel disease, TURP history, general anesthesia risks, or urethral strictures.

Inclusion Criteria

I am a man aged 18 or older.

My gland is smaller than 80 cc.

I am fit for IRE treatment.

Exclusion Criteria

I have had a prostate surgery known as TURP.

I have had radiation therapy to my pelvic area before.

I have had targeted treatment for a specific area of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Irreversible Electroporation (IRE) Treatment

Participants undergo the NanoKnife procedure under general anesthesia, targeting the prostate for ablation.

1 day

1 visit (in-person)

Radiotherapy (MRgRT)

Participants receive radiotherapy to the prostate and seminal vesicles with a total dose of 32.5 Gy in 5 fractions.

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 weeks post-MRgRT and 12 weeks post-IRE.

12 weeks

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are assessed for changes in prostate multiparametric MRI and quality of life measures every 3 months up to 60 months.

60 months

Treatment Details

Interventions

• IRreversible Electroporation and Magnetic Resonance guided Radiotherapy

Trial Overview The trial is testing the combination of Irreversible Electroporation (IRE) and Magnetic Resonance guided Radiotherapy (MRgRT) on men with intermediate risk prostate cancer. The goal is to see if this combined treatment can be done safely with low side effects while being effective for patients who meet specific criteria.

Participant Groups

Group I: Irreversible Electroporation and Radiotherapy Experimental Treatment 1 Intervention

IRreversible Electroporation and Magnetic Resonance guided Radiotherapy is already approved in European Union, United States for the following indications:

Approved in European Union as IRE for:

• Prostate cancer

Approved in United States as IRE for:

• Prostate cancer
• Soft tissue ablation

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 10 patients with localized prostate cancer treated with irreversible electroporation (IRE), there was a significant 73% reduction in prostate-specific antigen (PSA) levels after 6 months, indicating effective treatment.

The multiparametric MRI results showed that diffusion restriction disappeared in all but one patient, and the Prostate Imaging Reporting Data System scores improved, suggesting successful local ablation with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of clinical and mpMRI findings of irreversible electroporation therapy for the treatment of localized prostate cancer: Preliminary results. Güleryüz Kızıl, P., Altan, ŞA., Tarhan, NÇ., et al.[2022]

Imaging techniques like contrast-enhanced ultrasonography (CEUS) and multiparametric magnetic resonance imaging (mpMRI) are essential for planning and monitoring irreversible electroporation (IRE) treatments for prostate cancer, as they help visualize the ablation zone and provide feedback on treatment effectiveness.

The study found that the actual ablation zone volume (AZV) was significantly larger than planned, with CEUS showing an AZV 8.5 times larger than expected, indicating that imaging can help assess treatment outcomes and guide future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irreversible electroporation for the treatment of localized prostate cancer: a summary of imaging findings and treatment feedback. Scheltema, MJ., Postema, AW., de Bruin, DM., et al.[2022]

Irreversible electroporation (IRE) effectively ablated both healthy canine and cancerous human prostates in preliminary trials, demonstrating its potential as a safe treatment for prostate cancer while minimizing damage to surrounding tissues.

The study identified that the electric field strength required to achieve tissue necrosis in the prostate is significantly higher than previously reported, providing critical data to optimize IRE treatment protocols for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo characterization and numerical simulation of prostate properties for non-thermal irreversible electroporation ablation. Neal, RE., Millar, JL., Kavnoudias, H., et al.[2022]

In a study of 13 male patients with low-risk prostate cancer, irreversible electroporation (IRE) was performed, showing that the ablation area appeared either homogeneously or heterogeneously hypo attenuating on MRI, indicating different responses to the treatment.

Most patients exhibited a peripheral contrast enhancement after IRE, suggesting reactive hyperemia, which may indicate ongoing vascularization in the treated area, highlighting the need for careful imaging follow-up post-ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of irreversible electroporation of prostate cancer on microcirculation: Imaging findings in contrast-enhanced T1-weighted 3D MRI. Beyer, LP., Pregler, B., Verloh, N., et al.[2018]

In a study of 50 prostate cancer patients treated with irreversible electroporation (IRE), 74% were successfully treated with no local recurrence within six months, indicating IRE's efficacy in managing prostate cancer.

Contrast-enhanced ultrasound (CEUS) effectively identified residual tumors post-IRE, achieving a sensitivity of 76% and specificity of 81%, demonstrating its potential as a reliable imaging technique for monitoring treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound (CEUS) with parametric imaging after irreversible electroporation (IRE) of the prostate to assess the success of prostate cancer treatment. Jung, EM., Engel, M., Wiggermann, P., et al.[2021]

In a study of 30 men with localized prostate cancer, focal irreversible electroporation (IRE) demonstrated low urogenital toxicity, with stable erectile function and continence rates at 12 months post-treatment.

The treatment resulted in a significant reduction in prostate-specific antigen (PSA) levels, indicating promising oncologic outcomes, with a 17.9% rate of in-field treatment failure observed at 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided Irreversible Electroporation of Localized Prostate Cancer: Functional and Oncologic Outcomes. Collettini, F., Enders, J., Stephan, C., et al.[2020]

Irreversible Electroporation (IRE) is a safe and effective treatment for prostate cancer, showing comparable 5-year recurrence rates to standard radical prostatectomy while preserving urinary continence in all patients and resulting in only mild to moderate adverse effects.

In a study of 471 IRE treatments across 429 patients, IRE demonstrated versatility by being applicable for focal therapy, whole-gland ablation, and recurrent cases, making it a suitable option for various stages of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer treatment with Irreversible Electroporation (IRE): Safety, efficacy and clinical experience in 471 treatments. Guenther, E., Klein, N., Zapf, S., et al.[2020]

In a study of 425 localized prostate cancer patients treated with MR-guided ultrahypofractionated radiation therapy, significant declines in prostate-specific antigen levels were observed, indicating effective treatment outcomes over 12 months.

While the therapy was generally safe, with peak toxicity reported at 3 months, patients not receiving androgen deprivation therapy experienced significant worsening of erectile function by 12 months, highlighting the need for patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Adaptive Radiation Therapy for Prostate Cancer: The First Results from the MOMENTUM study-An International Registry for the Evidence-Based Introduction of Magnetic Resonance-Guided Adaptive Radiation Therapy. Teunissen, FR., Willigenburg, T., Tree, AC., et al.[2023]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Evaluation of clinical and mpMRI findings of irreversible electroporation therapy for the treatment of localized prostate cancer: Preliminary results. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

Irreversible electroporation for the treatment of localized prostate cancer: a summary of imaging findings and treatment feedback. [2022]

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

In vivo characterization and numerical simulation of prostate properties for non-thermal irreversible electroporation ablation. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of irreversible electroporation of prostate cancer on microcirculation: Imaging findings in contrast-enhanced T1-weighted 3D MRI. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound (CEUS) with parametric imaging after irreversible electroporation (IRE) of the prostate to assess the success of prostate cancer treatment. [2021]

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

Image-guided Irreversible Electroporation of Localized Prostate Cancer: Functional and Oncologic Outcomes. [2020]

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

Prostate cancer treatment with Irreversible Electroporation (IRE): Safety, efficacy and clinical experience in 471 treatments. [2020]

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

Magnetic Resonance-Guided Adaptive Radiation Therapy for Prostate Cancer: The First Results from the MOMENTUM study-An International Registry for the Evidence-Based Introduction of Magnetic Resonance-Guided Adaptive Radiation Therapy. [2023]