Study Summary
This trial is testing a new combined treatment for prostate cancer that is hoped to be both effective and safe.
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Study Objectives
2 Primary · 7 Secondary · Reporting Duration: Baseline, Every 3 months (up to 60 Months)
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 weeks
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
6 weeks
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
Month 60
Change in Impact of RTIRE on health-related quality of life as measured by International Index of Erectile Function (IIEF-5)
Change in Impact of RTIRE on health-related quality of life as measured by the International Prostate Symptom Score (IPSS)
Prostate Specific Antigen
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)
Month 12
Prostate multiparametric MRI changes
up to 12 months
Number of treatment-related adverse events
Trial Safety
Trial Design
1 Treatment Group
Irreversible Electroporation and Radiotherapy
1 of 1
Experimental Treatment
42 Total Participants · 1 Treatment Group
Primary Treatment: IRE & MRgRT · No Placebo Group · N/A
Irreversible Electroporation and Radiotherapy
Device
Experimental Group · 1 Intervention: IRE & MRgRT · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, every 3 months (up to 60 months)
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
989 Previous Clinical Trials
1,338,673 Total Patients Enrolled
46 Trials studying Prostate Cancer
49,147 Patients Enrolled for Prostate Cancer
Timothy McClurePrincipal InvestigatorWeill Medical College of Cornell University
Eligibility Criteria
Age 18 - 99 · Male Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The risk of metastasis is low in patients with intermediate risk prostate cancer.
You have a benign thyroid nodule that is < 80 cc in size.
You are a man aged ≥ 18 years.
Who else is applying?
What state do they live in?
| Pennsylvania | 50.0% |
| Hawaii | 50.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Weill Cornell Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Powell, Isaac J.. 2007. “Epidemiology and Pathophysiology of Prostate Cancer in African-american Men”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2006.09.024.
- NCCN Clinical Practice Guidelines in Oncology - Prostate Cancer (Version 2.2017). (2017)
- Kishan, Amar U., Audrey Dang, Alan J. Katz, Constantine A. Mantz, Sean P. Collins, Nima Aghdam, Fang-I Chu, et al.. 2019. “Long-term Outcomes of Stereotactic Body Radiotherapy for Low-risk and Intermediate-risk Prostate Cancer”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2018.8006.
- Widmark, Anders, Adalsteinn Gunnlaugsson, Lars Beckman, Camilla Thellenberg-Karlsson, Morten Hoyer, Magnus Lagerlund, Jon Kindblom, et al.. 2019. “Ultra-hypofractionated Versus Conventionally Fractionated Radiotherapy for Prostate Cancer: 5-year Outcomes of the HYPO-RT-PC Randomised, Non-inferiority, Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(19)31131-6.
- Kerkmeijer, Linda G. W., Veerle H. Groen, Floris J. Pos, Karin Haustermans, Evelyn M. Monninkhof, Robert Jan Smeenk, Martina Kunze-Busch, et al.. 2021. “Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients with Localized Prostate Cancer: Results from the FLAME Randomized Phase III Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02873.
- Mahase, Sean S., Debra D’Angelo, Josephine Kang, Jim C. Hu, Christopher E. Barbieri, and Himanshu Nagar. 2020. “Trends in the Use of Stereotactic Body Radiotherapy for Treatment of Prostate Cancer in the United States”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2019.20471.
- Katz, Alan J., Michael Santoro, Richard Ashley, Ferdinand Diblasio, and Matthew Witten. 2010. “Stereotactic Body Radiotherapy as Boost for Organ-confined Prostate Cancer”. Technology in Cancer Research & Treatment. SAGE Publications. doi:10.1177/153303461000900605.
- Vogelius, Ivan R., and Søren M. Bentzen. 2018. “Dose Response and Fractionation Sensitivity of Prostate Cancer After External Beam Radiation Therapy: A Meta-analysis of Randomized Trials”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2017.12.011.
- Morton, Gerard, Merrylee McGuffin, Hans T. Chung, Chia-Lin Tseng, Joelle Helou, Ananth Ravi, Patrick Cheung, et al.. 2020. “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”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2020.02.009.
- Draulans, Cédric, Uulke A. van der Heide, Karin Haustermans, Floris J. Pos, Jochem van der Voort van Zyp, Hans De Boer, Veerle H. Groen, et al.. 2020. “Primary Endpoint Analysis of the Multicentre Phase II Hypo-flame Trial for Intermediate and High Risk Prostate Cancer”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2020.03.015.
- Van Andel, G., A.P. Visser, M.C.C.M. Hulshof, S. Horenblas, and K.H. Kurth. 2003. “Health-related Quality of Life and Psychosocial Factors in Patients with Prostate Cancer Scheduled for Radical Prostatectomy or External Radiation Therapy”. BJU International. Wiley. doi:10.1046/j.1464-410x.2003.04321.x.
- 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.
- 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.
- 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.
- 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. Erratum In: JAMA Netw Open. 2020 Oct 1;3(10):e2027727.
- 2022. "Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05345444.
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