Combining Irreversible Electroporation and Radiotherapy for Prostate Cancer

Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)

This study is testing if combining a special cancer treatment called Irreversible Electroporation with targeted radiotherapy can safely help men with intermediate risk prostate cancer while reducing side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 99 Years
• Sex: Male
• Sponsor: Weill Medical College of Cornell University (other)
• Drugs / interventions: radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT05345444 on ClinicalTrials.gov

What this trial studies

This trial investigates the feasibility and safety of combining Irreversible Electroporation (IRE) with Magnetic Resonance guided Radiotherapy (MRgRT) in men with intermediate risk prostate cancer. A total of 42 subjects will undergo IRE followed by MRgRT, with the primary objective being to assess the feasibility of this combined approach at 12 weeks post-treatment. The study aims to minimize side effects while effectively treating prostate cancer, addressing the high risk of recurrence associated with IRE alone. The trial will evaluate patient outcomes and side effects over a 12-month follow-up period.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with histologically confirmed intermediate risk prostate cancer and specific tumor characteristics.

Not a fit: Patients with metastatic prostate cancer or those who have previously undergone focal therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for intermediate risk prostate cancer patients with fewer side effects.

How similar studies have performed: While the combination of IRE and MRgRT is a novel approach, similar focal therapies have shown promise in treating prostate cancer with reduced side effects.

Eligibility criteria

Inclusion Criteria:

1. Men aged ≥ 18
2. ECOG 0 - 1
3. Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
4. Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
5. Gland size \< 80 cc
6. Ability to undergo IRE
7. Ability to receive MRI-guided radiotherapy.
8. Ability to complete the HRQOL assessment surveys
9. Willingness to undergo 12 month follow up biopsy

Exclusion Criteria:

1. Prior history of focal therapy.
2. Prior history of receiving pelvic radiotherapy.
3. Patient with metastatic prostate cancer.
4. Patient with history of inflammatory bowel disease.
5. Inability to undergo general anesthesia
6. Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
7. 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.
8. History of bladder neck or urethral stricture.

Where this trial is running

New York, New York

• Weill Cornell Medicine — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Timothy McClure, MD — Weill Medical College of Cornell University
• Study coordinator: Sarah Yuan

Conditions: Prostate Cancer, Irreversible Electroporation, Radiotherapy