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IRE + MRgRT for Prostate Cancer (RTIRE Trial)

Q: Are there still open slots in this clinical trial?

Affirmative. Clinicaltrials.gov reveals that this medical study, which was originally posted on May 26th 2022, is actively seeking participants. A total of 10 individuals are needed at a single medical centre for the trial to be complete.

Q: How many people are actively involved in this research endeavor?

Affirmative. As stated on clinicaltrials.gov, this medical study commenced recruitment on May 26th 2022 and is currently seeking 10 individuals from a single site to partake in the trial.

Q: Is it possible to become a participant in this clinical experiment?

This clinical trial requires that participants are males aged 18 and upwards with a diagnosis of <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>. The eligibility criteria also stipulate that the individual must be an ECOG 0 - 1, have histologically confirmed favourable intermediate risk PC per NCCN guidelines, possess tumours no larger than 80cc in size, capable of undergoing IRE treatment, able to receive <a href="https://www.withpower.com/clinical-trials/mri">MRI</a>-guided radiotherapy treatments and complete HRQOL assessment surveys while agreeing to follow up biopsies over the course of 12 months.

Q: Does the research encompass participants older than 85 years of age?

To qualify for the trial, participants must be between 18 to 99 years old. However, there are 76 clinical trials available that cater to minors and 1316 medical studies targeting seniors over 65.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every 3 months (up to 60 months)

Awards & highlights

RTIRE Trial 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.Check my eligibility

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.See study design

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.

RTIRE Trial 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.

Select...

I am willing to have a biopsy after 12 months.

Select...

My MRI shows I have a moderate-grade prostate cancer.

Select...

I can undergo MRI-guided radiotherapy.

Select...

My MRI shows a specific type of prostate cancer (grade group 2).

Select...

I am fully active or have some restrictions but can still care for myself.

Select...

My prostate cancer is at an intermediate risk level.

RTIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 3 months (up to 60 months)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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)

Number of treatment-related adverse events

+4 more

RTIRE Trial Design

1Treatment groups

Experimental Treatment

Group I: Irreversible Electroporation and RadiotherapyExperimental Treatment1 Intervention

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,253 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,597 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open slots in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this medical study, which was originally posted on May 26th 2022, is actively seeking participants. A total of 10 individuals are needed at a single medical centre for the trial to be complete."

Answered by AI

How many people are actively involved in this research endeavor?

"Affirmative. As stated on clinicaltrials.gov, this medical study commenced recruitment on May 26th 2022 and is currently seeking 10 individuals from a single site to partake in the trial."

Answered by AI

Is it possible to become a participant in this clinical experiment?

"This clinical trial requires that participants are males aged 18 and upwards with a diagnosis of prostate cancer. The eligibility criteria also stipulate that the individual must be an ECOG 0 - 1, have histologically confirmed favourable intermediate risk PC per NCCN guidelines, possess tumours no larger than 80cc in size, capable of undergoing IRE treatment, able to receive MRI-guided radiotherapy treatments and complete HRQOL assessment surveys while agreeing to follow up biopsies over the course of 12 months."

Answered by AI

Does the research encompass participants older than 85 years of age?

"To qualify for the trial, participants must be between 18 to 99 years old. However, there are 76 clinical trials available that cater to minors and 1316 medical studies targeting seniors over 65."

Answered by AI