Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE) (NCT05345444) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
United States48 participantsStarted 2022-05-26
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
Timeframe: 12 weeks
2
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
Timeframe: 6 weeks
3
Proportion of patients who remain cancer-free
Timeframe: 12 months
Trial details
NCT IDNCT05345444
SponsorWeill Medical College of Cornell University
. 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.