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

NCT05345444 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 22-03024562
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. Ultimately, RTIRE may provide optimal treatment for intermediate risk prostate cancer patients.

Conditions

Prostate Cancer

Keywords

Irreversible Electroporation; Radiotherapy

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  12 months

Secondary Outcomes (7)

• Number of treatment-related adverse events

  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

  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)

  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)

  Baseline, Every 3 months (up to 60 Months)

• Prostate multiparametric MRI changes

  Baseline, immediately post IRE procedure,3 month post procedure, and 12 months post procedure

Study Arms (1)

Irreversible Electroporation and Radiotherapy

EXPERIMENTAL

Device: IRE & MRgRT

Interventions

IRE & MRgRT DEVICE

Subjects will undergo Irreversible electroporation(IRE) followed by Magnetic resonance guided radiotherapy (MRgRT)

Also known as: RTIRE

Irreversible Electroporation and Radiotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Males with prostate cancer (participant eligibility is not based on self-representation of gender identity).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to receive MRI-guided radiotherapy.
• Ability to complete the HRQOL assessment surveys
• Willingness to undergo 12 month follow up biopsy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (12)

• 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.

  PMID: 18304396 BACKGROUND

• NCCN Clinical Practice Guidelines in Oncology - Prostate Cancer (Version 2.2017). (2017)

  BACKGROUND

• 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.

  PMID: 30735235 BACKGROUND

• Mahase 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.

  PMID: 32022878 BACKGROUND

• Kang 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.

  PMID: 21528663 BACKGROUND

• Morton 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.

  PMID: 32146259 BACKGROUND

• Widmark 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.

  PMID: 31227373 BACKGROUND

• Vogelius 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.

  PMID: 29485063 BACKGROUND

• Kerkmeijer 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.

  PMID: 33471548 BACKGROUND

• Draulans 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.

  PMID: 32247206 BACKGROUND

• Van 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.

  PMID: 12887470 BACKGROUND

• Diven 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.

  PMID: 39054460 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Timothy McClure, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: May 26, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)