Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE) (RTIRE)

March 20, 2026 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine feasibility of combining IRE and SBRT. Feasibility is defined at 80% of subjects assessed at 12 weeks post-IRE/6 weeks post-MRgRT within 1 year from first subject enrollment.

Rationale

  1. Focal therapy with IRE offers a low side effect profile of treatment but risk of recurrence
  2. Lower dose MRgRT offers the potential benefit of limiting radiation dose received by normal tissues, namely the bladder and rectum, with advanced MR image guidance, real- time volume adaptability and dose delivery techniques.
  3. Combined IRE and MRgRT may provide optimal treatment of prostate cancer while minimizing side effects

Patients with intermediate risk prostate cancer are at higher risk of progressing while on active surveillance when compared to men with low-risk prostate cancer. The benefits of definitive treatment with RT or surgery may not outweigh the risks of surveillance in intermediate risk prostate cancer patients due to increased morbidity of treatment. Focal therapy with IRE is effective in treating prostate cancer with minimal side effects but has a high risk of recurrence, especially in patients with nontreated low risk prostate cancer. Lower dose RT may treat low risk prostate cancer and reduce the risk of recurrence after treatment. RTIRE may be a treatment option for some patients with intermediate risk prostate cancer.

Study Completion A participant is considered to have completed the study if he has completed all phases of the study including the last visit or the last scheduled procedure. The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial globally.

Treatment Phase Irreversible Electroporation Subjects will be placed in the dorsal lithotomy position under sterile technique. The NanoKnife procedure will be carried out under general anesthesia. A Foley catheter will be placed to aid in draining the bladder during treatment.

Prior to NanoKnife treatment, subjects will receive an antibiotic of choice selected by the treating physician via intravenous infusion to reduce the chance of infection. A negative urine culture will be obtained prior to treatment.

The area of the prostate that was positive for cancer based on the transperineal prostate biopsy will be targeted for ablation via the NanoKnife System. An MRI/TRUS fusion device probe will be placed in the rectum and the prostate will be visualized in both sagittal and axial views. The ultrasound grid which was used during the mapping biopsy will be oriented using anatomical landmarks and used to identify the location of the positive biopsy cores. The NanoKnife Single Electrode Probes will be percutaneously inserted into the prostate through the perineum using MRI/TRUS fusion guidance and the ultrasound grid for guidance. The location of the probes will be documented via ultrasound imaging After placement of the NanoKnife probes in the prostate and immediately prior to NanoKnife treatment, a nondepolarizing neuromuscular blocking agent will be administered to reduce skeletal muscle contraction which is associated with the use of the NanoKnife System. The pulse treatment dose will be determined using standard protocol and a pre-treatment checklist will be performed prior to ablation. Post ablation assessment will be performed by assessing changes in voltage parameters during treatment and after confirmation of adequate ablation the probes will be removed. An immediate post ablation MRI will also be assessed to determine the effectiveness of ablation. The Foley catheter will be left in place after the procedure and removed at the discretion of the treating physician. The IRE treatment will be scheduled as an outpatient procedure. Patients will be discharged from the hospital with a foley catheter and scheduled for a void trial prior to removal. The void trial will include a post void residual to confirm safety for catheter removal.

Radiotherapy After consent, eligibility verification, and IRE patients will undergo CT/MRI simulation and radiotherapy planning. Patients will receive treatment to the prostate + seminal vesicles to 32.5 Gy in 5 fractions.

Immobilization Immobilization of the hips and feet using a cradle should be considered. Each patient will be positioned in the supine position. Prone positioning for treatment is not permitted.

Simulation Treatment planning CT/MRI will be performed with vac loc immobilization. Patients will be advised to drink 2-3 cups of water 30 minutes prior to the MRI simulation to allow for a comfortably full bladder, as tolerated.

Rectal Filling - An overly distended rectum can introduce a systematic positioning error that may increase the probability of missing the clinical target volume (CTV). Patients should be simulated with the rectum as empty as possible and <3 cm in the anterior-posterior dimension is ideal. Rectal balloons for planning and treatment are not permitted. Enema may be necessary for subjects. Bladder Filling - Patients should also have a comfortably full bladder (the patient should not be uncomfortable at simulation because it is likely that he will have more difficulty maintaining a full bladder during treatment).

Contours The prostate + seminal vesicles will be contoured as the clinical target volume (CTV). The planning target volume (PTV) expansion for the CTV will be 2 mm. The rectum will be drawn from the bottom of the ischial tuberosities to the sigmoid flexure. The bladder, bladder wall (bladder - 4 mm isotropic constriction), urethra (contoured with 10 mm brush on sagittal view), femoral heads, and penile bulb will also be contoured as normal structures.

Dose/Treatment Planning Parameters PTV will be treated to the prescribed dose 32.5 Gy in 5 fractions. VPrescription Dose (volume of the PTV receiving Prescription Dose) should be ≥ 95% and not exceed 115% (hotspot) Urethra should be expanded with a 3 mm PRV and should not receive more than the prescription dose

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men aged ≥ 18
  2. ECOG 0 - 1
  3. Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
  4. Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
  5. Gland size < 80 cc
  6. Ability to undergo IRE
  7. Ability to receive MRI-guided radiotherapy.
  8. Ability to complete the HRQOL assessment surveys
  9. Willingness to undergo 12 month follow up biopsy

Exclusion Criteria:

  1. Prior history of focal therapy.
  2. Prior history of receiving pelvic radiotherapy.
  3. Patient with metastatic prostate cancer.
  4. Patient with history of inflammatory bowel disease.
  5. Inability to undergo general anesthesia
  6. Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
  7. Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.
  8. History of bladder neck or urethral stricture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irreversible Electroporation and Radiotherapy
Device: IRE & MRgRT
Subjects will undergo Irreversible electroporation(IRE) followed by Magnetic resonance guided radiotherapy (MRgRT)
Other Names:
  • RTIRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
Time Frame: 12 weeks
Feasibility is defined at 80% of subjects (8 subjects) assessed at 12-week post-IRE
12 weeks
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
Time Frame: 6 weeks
Feasibility is defined as 80% of subjects (8 subjects) assessed at 6 weeks post-MRgRT within 1 year
6 weeks
Proportion of patients who remain cancer-free
Time Frame: 12 months
Phase II primary objective: determine the potential efficacy of combined IRE and SBRT at the 1-year follow-up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-related adverse events
Time Frame: up to 12 months
up to 12 months
Oncologic efficacy of RTIRE as measure by the number of subjects with presence of clinically significant (Greater than grade group1) prostate cancer
Time Frame: 12 months
12 months
change in Impact of RTIRE on health-related quality of life as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Time Frame: Baseline, Every 3 months (up to 60 Months)
Questionnaire to help assess overall quality of life in patients with prostate cancer. This questionnaire is a 1-page, 16-item questionnaire that is designed to assess urinary incontinence, urinary irritation, bowel irritation, sexual health and hormonal health after prostate cancer surgery. Each domain is scored separately from a scale of 0 to 12. The minimum symptom score in each domain is a 0 and the maximum symptom score in each domain is a 12.
Baseline, Every 3 months (up to 60 Months)
Change in Impact of RTIRE on health-related quality of life as measured by the International Prostate Symptom Score (IPSS)
Time Frame: Baseline, Every 3 months (up to 60 Months)
Score of 0 to 7 points:Mild symptoms 8 to 19 points:Moderate symptoms 20 to 35 points:Severe symptoms
Baseline, Every 3 months (up to 60 Months)
Prostate multiparametric MRI changes
Time Frame: Baseline, immediately post IRE procedure,3 month post procedure, and 12 months post procedure
Assess pre and post prostate mpMRI changes
Baseline, immediately post IRE procedure,3 month post procedure, and 12 months post procedure
Change in Impact of RTIRE on health-related quality of life as measured by International Index of Erectile Function (IIEF-5)
Time Frame: Baseline, Every 3 months (up to 60 Months)
For IIEF-5 severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), no ED (22-25).
Baseline, Every 3 months (up to 60 Months)
Prostate Specific Antigen
Time Frame: Baseline, Every 3 months (up to 60 Months)
Following the PSA measure
Baseline, Every 3 months (up to 60 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Timothy McClure, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-03024562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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