IRE & MRgRT for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate CancerIRE & MRgRT - Device
Eligibility
18 - 99
Male
What conditions do you have?
Select

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: Device

Trial 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?
Pennsylvania50.0%
Hawaii50.0%
How old are they?
65+100.0%
What site did they apply to?
Weill Cornell Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References