ACTIVE_NOT_RECRUITING

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

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Conditions

Prostate CancerIrreversible ElectroporationRadiotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-26
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05345444

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men aged ≥ 18
  2. 2. ECOG 0 - 1
  3. 3. Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
  4. 4. Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
  5. 5. Gland size \< 80 cc
  6. 6. Ability to undergo IRE
  7. 7. Ability to receive MRI-guided radiotherapy.
  8. 8. Ability to complete the HRQOL assessment surveys
  9. 9. Willingness to undergo 12 month follow up biopsy
  1. 1. Prior history of focal therapy.
  2. 2. Prior history of receiving pelvic radiotherapy.
  3. 3. Patient with metastatic prostate cancer.
  4. 4. Patient with history of inflammatory bowel disease.
  5. 5. Inability to undergo general anesthesia
  6. 6. Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
  7. 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. 8. History of bladder neck or urethral stricture.

Contacts and Locations

Principal Investigator

Timothy McClure, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-26
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-05-26
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Irreversible Electroporation
  • Radiotherapy

Additional Relevant MeSH Terms

  • Prostate Cancer