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Procedure

IRE + MRgRT for Prostate Cancer (RTIRE Trial)

N/A
Recruiting
Led By Timothy McClure
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men aged ≥ 18
Gland size < 80 cc
Must not have
Prior TURP.
Prior history of receiving pelvic radiotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 3 months (up to 60 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combined treatment for prostate cancer that is hoped to be both effective and safe.

Who is the study for?
Men over 18 with intermediate risk prostate cancer, specifically grade group 2 or 3 as seen in MRI. They must be able to undergo IRE and MRgRT treatments, have a prostate gland size under 80 cc, an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity), and agree to follow-up biopsies. Excluded are those with metastatic cancer, prior pelvic radiotherapy or focal therapy, inflammatory bowel disease, TURP history, general anesthesia risks, or urethral strictures.
What is being tested?
The trial is testing the combination of Irreversible Electroporation (IRE) and Magnetic Resonance guided Radiotherapy (MRgRT) on men with intermediate risk prostate cancer. The goal is to see if this combined treatment can be done safely with low side effects while being effective for patients who meet specific criteria.
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort from the procedure itself like bruising or bleeding at the needle insertion site for IRE; skin irritation from radiation; fatigue; urinary issues such as frequency and urgency due to proximity to bladder; erectile dysfunction due to nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
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My gland is smaller than 80 cc.
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I am fit for IRE treatment.
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My prostate cancer is at an intermediate stage, according to NCCN guidelines.
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I am willing to have a biopsy after 12 months.
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My MRI shows I have a moderate-grade prostate cancer.
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I can undergo MRI-guided radiotherapy.
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My MRI shows a specific type of prostate cancer (grade group 2).
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I am fully active or have some restrictions but can still care for myself.
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My prostate cancer is at an intermediate risk level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a prostate surgery known as TURP.
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I have had radiation therapy to my pelvic area before.
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I have had targeted treatment for a specific area of my body.
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I cannot have surgery that requires being put to sleep.
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I have had a narrowing of my bladder neck or urethra.
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I cannot be positioned for certain medical procedures due to physical limitations.
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I have prostate cancer that has spread to other parts of my body.
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I have a history of inflammatory bowel disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 3 months (up to 60 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 3 months (up to 60 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
Secondary study objectives
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
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Irreversible Electroporation and RadiotherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,081 Previous Clinical Trials
1,137,997 Total Patients Enrolled
19 Trials studying Prostate Cancer
27,955 Patients Enrolled for Prostate Cancer
Timothy McClurePrincipal InvestigatorWeill Medical College of Cornell University

Media Library

IRreversible Electroporation and Magnetic Resonance guided Radiotherapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05345444 — N/A
Prostate Cancer Research Study Groups: Irreversible Electroporation and Radiotherapy
Prostate Cancer Clinical Trial 2023: IRreversible Electroporation and Magnetic Resonance guided Radiotherapy Highlights & Side Effects. Trial Name: NCT05345444 — N/A
IRreversible Electroporation and Magnetic Resonance guided Radiotherapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05345444 — N/A
~0 spots leftby Nov 2024
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