IRE + MRgRT for Prostate Cancer
(RTIRE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byTimothy McClure, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Metastatic cancer, Inflammatory bowel disease, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
12467How 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.
12368Eligibility 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.
+8 more
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.
+5 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Irreversible Electroporation and RadiotherapyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell MedicineNew York, NY
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
References
Evaluation of clinical and mpMRI findings of irreversible electroporation therapy for the treatment of localized prostate cancer: Preliminary results. [2022]To evaluate early clinical and multiparametric prostate magnetic resonance imaging (mpMRI) results of irreversible electroporation (IRE) efficiency in treatment of localized prostate cancer.
Irreversible electroporation for the treatment of localized prostate cancer: a summary of imaging findings and treatment feedback. [2022]Imaging plays a crucial role in ablative therapies for prostate cancer (PCa). Irreversible electroporation (IRE) is a new treatment modality used for focal treatment of PCa. We aimed to demonstrate what imaging modalities can be used by descriptively reporting contrast-enhanced ultrasonography (CEUS), multiparametric magnetic resonance imaging (mpMRI), and grey-scale transrectal ultrasound (TRUS) results. Furthermore, we aimed to correlate quantitatively the ablation zone seen on mpMRI and CEUS with treatment planning to provide therapy feedback.
In vivo characterization and numerical simulation of prostate properties for non-thermal irreversible electroporation ablation. [2022]Irreversible electroporation (IRE) delivers brief electric pulses to attain non-thermal focal ablation that spares vasculature and other sensitive systems. It is a promising prostate cancer treatment due to sparing of the tissues associated with morbidity risk from conventional therapies. IRE effects depend on electric field strength and tissue properties. These characteristics are organ-dependent, affecting IRE treatment outcomes. This study characterizes the relevant properties to improve treatment planning and outcome predictions for IRE prostate cancer treatment.
Effect of irreversible electroporation of prostate cancer on microcirculation: Imaging findings in contrast-enhanced T1-weighted 3D MRI. [2018]Irreversible electroporation (IRE) is a novel focal ablation technique applicable for treatment of prostate cancer (PCa). We aim to evaluate imaging findings of T1-weighted contrast-enhanced MRI after percutaneous IRE of low-risk PCa.
Contrast enhanced ultrasound (CEUS) with parametric imaging after irreversible electroporation (IRE) of the prostate to assess the success of prostate cancer treatment. [2021]The aim of this study was to assess the success of irreversible electroporation (IRE) in prostate cancer and to differentiate between reactive changes and tumor.
Image-guided Irreversible Electroporation of Localized Prostate Cancer: Functional and Oncologic Outcomes. [2020]Background Irreversible electroporation (IRE) is a nonthermal ablative method based on the formation of nanoscale defects in cell membranes leading to cell death. Clinical experience with the technique for treatment of prostate cancer remains limited. Purpose To evaluate urogenital toxicity and oncologic outcome of MRI-transrectal US fusion-guided IRE of localized prostate cancer. Materials and Methods In this prospective study, men with biopsy-proven, treatment-naive, low- to intermediate-risk prostate cancer (prostate-specific antigen [PSA], ≤15 ng/mL; Gleason score, ≤3 + 4; clinical stage, ≤T2c; lesion size at multiparametric MRI, ≤20 mm) underwent focal MRI/transrectal US fusion-guided IRE between July 2014 and July 2017. Primary end point was the urogenital toxicity profile of focal IRE by using participant-reported questionnaires. Secondary end points were biochemical, histologic, and imaging measures of oncologic control. Analyses were performed by using nonparametric and χ2 test statistics. Results Thirty men were included (median age, 65.5 years); mean PSA level was 8.65 ng/mL and mean tumor size was 13.5 mm. One grade III adverse event (urethral stricture) was recorded. The proportion of men with erection sufficient for penetration was 83.3% (25 of 30) at baseline and 79.3% (23 of 29; P > .99) at 12 months. Leak-free and pad-free continence rate was 90% (27 of 30) at baseline and 86.2% (25 of 29; P > .99) at 12 months. Urogenital function remained stable at 12 months according to changes in the modified International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms, or ICIQ-MLUTS, and the International Index of Erectile Function, or IIEF-5, questionnaires (P = .58 and P = .07, respectively). PSA level decreased from a baseline median value of 8.65 ng/mL (interquartile range, 5-11.4 ng/mL) to 2.35 ng/mL (interquartile range, 1-3.4 ng/mL) at 12 months (P < .001). At 6 months, 28 of 30 participants underwent posttreatment biopsy. The rate of in-field treatment failure was 17.9% (five of 28) as determined with multiparametric prostate MRI and targeted biopsies at 6 months. Conclusion After a median follow-up of 20 months, focal irreversible electroporation of localized prostate cancer was associated with low urogenital toxicity and promising oncologic outcomes. © RSNA, 2019 Online supplemental material is available for this article.
Prostate cancer treatment with Irreversible Electroporation (IRE): Safety, efficacy and clinical experience in 471 treatments. [2020]Irreversible Electroporation (IRE) is a novel image-guided tissue ablation technology that induces cell death via very short but strong pulsed electric fields. IRE has been shown to have preserving properties towards vessels and nerves and the extracellular matrix. This makes IRE an ideal candidate to treat prostate cancer (PCa) where other treatment modalities frequently unselectively destroy surrounding structures inducing severe side effects like incontinence or impotence. We report the retrospective assessment of 471 IRE treatments in 429 patients of all grades and stages of PCa with 6-year maximum follow-up time.
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]Magnetic resonance (MR)-guided radiation therapy (MRgRT) is a new technique for treatment of localized prostate cancer (PCa). We report the 12-month outcomes for the first PCa patients treated within an international consortium (the MOMENTUM study) on a 1.5T MR-Linac system with ultrahypofractionated radiation therapy.