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


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05345444

Sponsor: Weill Medical College of Cornell University

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: Male

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.

View trial on ClinicalTrials.gov