Prostate CancerRTIRENCT05345444
Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
A study testing IRE & MRgRT in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- IRE & MRgRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged ≥ 18
- ECOG 0 - 1
- Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
- Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
- Gland size < 80 cc
- Ability to undergo IRE
Show all 9Show fewer
- Ability to receive MRI-guided radiotherapy.
- Ability to complete the HRQOL assessment surveys
- Willingness to undergo 12 month follow up biopsy
Who cannot join
- Prior history of focal therapy.
- Prior history of receiving pelvic radiotherapy.
- Patient with metastatic prostate cancer.
- Patient with history of inflammatory bowel disease.
- Inability to undergo general anesthesia
- Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
- 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.
- History of bladder neck or urethral stricture.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Focal therapy with IRE offers a low side effect profile of treatment but risk of recurrence
- 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.
- 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
- Conditions
- Prostate Cancer
- Being tested
- IRE & MRgRT
- Keywords
- Irreversible Electroporation, Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE & MRgRTDevice
Also called RTIRE
Subjects will undergo Irreversible electroporation(IRE) followed by Magnetic resonance guided radiotherapy (MRgRT)
| Study group | Role | What they receive |
|---|---|---|
| Irreversible Electroporation and Radiotherapy | Experimental | Not described Receives: Device: IRE & MRgRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
Feasibility is defined at 80% of subjects (8 subjects) assessed at 12-week post-IRE
Measured: 12 weeks
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
Feasibility is defined as 80% of subjects (8 subjects) assessed at 6 weeks post-MRgRT within 1 year
Measured: 6 weeks
Proportion of patients who remain cancer-free
Phase II primary objective: determine the potential efficacy of combined IRE and SBRT at the 1-year follow-up.
Measured: 12 months
Secondary outcomes (7)
Number of treatment-related adverse events
Measured: 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
Measured: 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)
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.
Measured: 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)
Score of 0 to 7 points:Mild symptoms 8 to 19 points:Moderate symptoms 20 to 35 points:Severe symptoms
Measured: Baseline, Every 3 months (up to 60 Months)
Prostate multiparametric MRI changes
Assess pre and post prostate mpMRI changes
Measured: 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)
For IIEF-5 severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), no ED (22-25).
Measured: Baseline, Every 3 months (up to 60 Months)
Prostate Specific Antigen
Following the PSA measure
Measured: Baseline, Every 3 months (up to 60 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start26 May 2022
- Primary completion24 Apr 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy McClure, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345444
- Sponsor's protocol ID
- 22-03024562
- Acronym
- RTIRE
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2022
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Haas GP, Delongchamps N, Brawley OW, Wang CY, de la Roza G. The worldwide epidemiology of prostate cancer: perspectives from autopsy studies. Can J Urol. 2008 Feb;15(1):3866-71.
PubMed 18304396NCCN Clinical Practice Guidelines in Oncology - Prostate Cancer (Version 2.2017). (2017)
Kishan AU, Dang A, Katz AJ, Mantz CA, Collins SP, Aghdam N, Chu FI, Kaplan ID, Appelbaum L, Fuller DB, Meier RM, Loblaw DA, Cheung P, Pham HT, Shaverdian N, Jiang N, Yuan Y, Bagshaw H, Prionas N, Buyyounouski MK, Spratt DE, Linson PW, Hong RL, Nickols NG, Steinberg ML, Kupelian PA, King CR. Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer. JAMA Netw Open. 2019 Feb 1;2(2):e188006. doi: 10.1001/jamanetworkopen.2018.8006.
PubMed 30735235Mahase SS, D'Angelo D, Kang J, Hu JC, Barbieri CE, Nagar H. Trends in the Use of Stereotactic Body Radiotherapy for Treatment of Prostate Cancer in the United States. JAMA Netw Open. 2020 Feb 5;3(2):e1920471. doi: 10.1001/jamanetworkopen.2019.20471.
PubMed 32022878Kang JK, Cho CK, Choi CW, Yoo S, Kim MS, Yang K, Yoo H, Kim JH, Seo YS, Lee DH, Jo M. Image-guided stereotactic body radiation therapy for localized prostate cancer. Tumori. 2011 Jan-Feb;97(1):43-8. doi: 10.1177/030089161109700109.
PubMed 21528663Morton G, McGuffin M, Chung HT, Tseng CL, Helou J, Ravi A, Cheung P, Szumacher E, Liu S, Chu W, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Radiother Oncol. 2020 May;146:90-96. doi: 10.1016/j.radonc.2020.02.009. Epub 2020 Mar 5.
PubMed 32146259Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.
PubMed 31227373Vogelius IR, Bentzen SM. Dose Response and Fractionation Sensitivity of Prostate Cancer After External Beam Radiation Therapy: A Meta-analysis of Randomized Trials. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):858-865. doi: 10.1016/j.ijrobp.2017.12.011. Epub 2017 Dec 15.
PubMed 29485063Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, van Vulpen M, Draulans C, van den Bergh L, Isebaert S, van der Heide UA. Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):787-796. doi: 10.1200/JCO.20.02873. Epub 2021 Jan 20.
PubMed 33471548Draulans C, van der Heide UA, Haustermans K, Pos FJ, van der Voort van Zyp J, De Boer H, Groen VH, Monninkhof EM, Smeenk RJ, Kunze-Busch M, De Roover R, Depuydt T, Isebaert S, Kerkmeijer LGW. Primary endpoint analysis of the multicentre phase II hypo-FLAME trial for intermediate and high risk prostate cancer. Radiother Oncol. 2020 Jun;147:92-98. doi: 10.1016/j.radonc.2020.03.015. Epub 2020 Apr 1.
PubMed 32247206Van Andel G, Visser AP, Hulshof MC, Horenblas S, Kurth KH. Health-related quality of life and psychosocial factors in patients with prostate cancer scheduled for radical prostatectomy or external radiation therapy. BJU Int. 2003 Aug;92(3):217-22. doi: 10.1046/j.1464-410x.2003.04321.x.
PubMed 12887470Diven M, Ballman K, Marciscano A, Barbieri C, Piscopo J, Wang S, Nagar H, McClure T. Radiation therapy and IRreversible electroporation for intermediate risk prostate cancer (RTIRE). BMC Urol. 2024 Jul 25;24(1):151. doi: 10.1186/s12894-024-01506-8.
PubMed 39054460
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
- ClinicalTrials.gov ID
- NCT05345444
- Acronym / sponsor ID
- RTIRE / 22-03024562
- Conditions
- Prostate Cancer
- Keywords
- Irreversible Electroporation, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Focal therapy with IRE offers a low side effect profile of treatment but risk of recurrence
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irreversible Electroporation and Radiotherapy | Experimental | Device: IRE & MRgRT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men aged ≥ 18
- ECOG 0 - 1
- Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
- Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
- Gland size < 80 cc
Key exclusion criteria (8 listed)
- Prior history of focal therapy.
- Prior history of receiving pelvic radiotherapy.
- Patient with metastatic prostate cancer.
- Patient with history of inflammatory bowel disease.
- Inability to undergo general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRE & MRgRTAlso: RTIRESubjects will undergo Irreversible electroporation(IRE) followed by Magnetic resonance guided radiotherapy (MRgRT) | Device | Irreversible Electroporation and Radiotherapy |
Primary outcome
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
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
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.
7 secondary outcomes
Number of treatment-related adverse events
Time frame: 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
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)
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)
Prostate multiparametric MRI changes
Time frame: 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)
Prostate Specific Antigen
Time frame: Baseline, Every 3 months (up to 60 Months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 18304396Haas GP, Delongchamps N, Brawley OW, Wang CY, de la Roza G. The worldwide epidemiology of prostate cancer: perspectives from autopsy studies. Can J Urol. 2008 Feb;15(1):3866-71.
- BackgroundNCCN Clinical Practice Guidelines in Oncology - Prostate Cancer (Version 2.2017). (2017)
- Background: PubMed 30735235Kishan AU, Dang A, Katz AJ, Mantz CA, Collins SP, Aghdam N, Chu FI, Kaplan ID, Appelbaum L, Fuller DB, Meier RM, Loblaw DA, Cheung P, Pham HT, Shaverdian N, Jiang N, Yuan Y, Bagshaw H, Prionas N, Buyyounouski MK, Spratt DE, Linson PW, Hong RL, Nickols NG, Steinberg ML, Kupelian PA, King CR. Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer. JAMA Netw Open. 2019 Feb 1;2(2):e188006. doi: 10.1001/jamanetworkopen.2018.8006.
- Background: PubMed 32022878Mahase SS, D'Angelo D, Kang J, Hu JC, Barbieri CE, Nagar H. Trends in the Use of Stereotactic Body Radiotherapy for Treatment of Prostate Cancer in the United States. JAMA Netw Open. 2020 Feb 5;3(2):e1920471. doi: 10.1001/jamanetworkopen.2019.20471.
- Background: PubMed 21528663Kang JK, Cho CK, Choi CW, Yoo S, Kim MS, Yang K, Yoo H, Kim JH, Seo YS, Lee DH, Jo M. Image-guided stereotactic body radiation therapy for localized prostate cancer. Tumori. 2011 Jan-Feb;97(1):43-8. doi: 10.1177/030089161109700109.
- Background: PubMed 32146259Morton G, McGuffin M, Chung HT, Tseng CL, Helou J, Ravi A, Cheung P, Szumacher E, Liu S, Chu W, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Radiother Oncol. 2020 May;146:90-96. doi: 10.1016/j.radonc.2020.02.009. Epub 2020 Mar 5.
- Background: PubMed 31227373Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.
- Background: PubMed 29485063Vogelius IR, Bentzen SM. Dose Response and Fractionation Sensitivity of Prostate Cancer After External Beam Radiation Therapy: A Meta-analysis of Randomized Trials. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):858-865. doi: 10.1016/j.ijrobp.2017.12.011. Epub 2017 Dec 15.
- Background: PubMed 33471548Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, van Vulpen M, Draulans C, van den Bergh L, Isebaert S, van der Heide UA. Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):787-796. doi: 10.1200/JCO.20.02873. Epub 2021 Jan 20.
- Background: PubMed 32247206Draulans C, van der Heide UA, Haustermans K, Pos FJ, van der Voort van Zyp J, De Boer H, Groen VH, Monninkhof EM, Smeenk RJ, Kunze-Busch M, De Roover R, Depuydt T, Isebaert S, Kerkmeijer LGW. Primary endpoint analysis of the multicentre phase II hypo-FLAME trial for intermediate and high risk prostate cancer. Radiother Oncol. 2020 Jun;147:92-98. doi: 10.1016/j.radonc.2020.03.015. Epub 2020 Apr 1.
- Background: PubMed 12887470Van Andel G, Visser AP, Hulshof MC, Horenblas S, Kurth KH. Health-related quality of life and psychosocial factors in patients with prostate cancer scheduled for radical prostatectomy or external radiation therapy. BJU Int. 2003 Aug;92(3):217-22. doi: 10.1046/j.1464-410x.2003.04321.x.
- Derived from this study: PubMed 39054460Diven M, Ballman K, Marciscano A, Barbieri C, Piscopo J, Wang S, Nagar H, McClure T. Radiation therapy and IRreversible electroporation for intermediate risk prostate cancer (RTIRE). BMC Urol. 2024 Jul 25;24(1):151. doi: 10.1186/s12894-024-01506-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy McClure, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRE & MRgRT in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345444, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.