Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
Running, not enrolling · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05345444
- Run by
- Weill Medical College of Cornell University
- People needed
- 48
- Starts
- 2022-05-26
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Willingness to undergo 12 month follow up biopsy
You may not qualify if…
- Prior history of focal therapy.
- Prior history of receiving pelvic radiotherapy.
- Patient with metastatic prostate cancer.
- 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.
- History of bladder neck or urethral stricture.
Where it is running
- Weill Cornell Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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