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

Description

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.

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Timothy McClure, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2027-04