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Trial record 1 of 17 for:    radiation therapy irreversible electroporation
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Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE) (RTIRE)

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ClinicalTrials.gov Identifier: NCT05345444
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: IRE & MRgRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Irreversible Electroporation and Radiotherapy Device: IRE & MRgRT
Subjects will undergo Irreversible electroporation(IRE) followed by Magnetic resonance guided radiotherapy (MRgRT)
Other Name: RTIRE




Primary Outcome Measures :
  1. Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE [ Time Frame: 12 weeks ]
    Feasibility is defined at 80% of subjects (8 subjects) assessed at 12-week post-IRE

  2. Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year [ Time Frame: 6 weeks ]
    Feasibility is defined as 80% of subjects (8 subjects) assessed at 6 weeks post-MRgRT within 1 year


Secondary Outcome Measures :
  1. Number of treatment-related adverse events [ Time Frame: up to 12 months ]
  2. Oncologic efficacy of RTIRE as measure by the number of subjects with presence of clinically significant (Greater than grade group1) prostate cancer [ Time Frame: 12 months ]
  3. change in Impact of RTIRE on health-related quality of life as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) [ Time Frame: Baseline, Every 3 months (up to 60 Months) ]
    Questionnaire to help assess overall quality of life in patients with prostate cancer. This questionnaire is a 1-page, 16-item questionnaire that is designed to assess urinary incontinence, urinary irritation, bowel irritation, sexual health and hormonal health after prostate cancer surgery. Each domain is scored separately from a scale of 0 to 12. The minimum symptom score in each domain is a 0 and the maximum symptom score in each domain is a 12.

  4. Change in Impact of RTIRE on health-related quality of life as measured by the International Prostate Symptom Score (IPSS) [ Time Frame: Baseline, Every 3 months (up to 60 Months) ]
    Score of 0 to 7 points:Mild symptoms 8 to 19 points:Moderate symptoms 20 to 35 points:Severe symptoms

  5. Prostate multiparametric MRI changes [ Time Frame: Baseline, immediately post IRE procedure,3 month post procedure, and 12 months post procedure ]
    Assess pre and post prostate mpMRI changes

  6. Change in Impact of RTIRE on health-related quality of life as measured by International Index of Erectile Function (IIEF-5) [ Time Frame: Baseline, Every 3 months (up to 60 Months) ]
    For IIEF-5 severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), no ED (22-25).

  7. Prostate Specific Antigen [ Time Frame: Baseline, Every 3 months (up to 60 Months) ]
    Following the PSA measure



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with prostate cancer (participant eligibility is not based on self-representation of gender identity).
Accepts Healthy Volunteers:   No
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 TURP.
  2. Prior history of focal therapy.
  3. Prior history of receiving pelvic radiotherapy.
  4. Patient with metastatic prostate cancer.
  5. Patient with history of inflammatory bowel disease.
  6. Inability to undergo general anesthesia
  7. Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
  8. 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.
  9. History of bladder neck or urethral stricture.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05345444


Contacts
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Contact: Sharanya Chandrasekhar 646-962-3110 shc2043@med.cornell.edu
Contact: Pragya Yadav 646-962-2196 pry2003@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Sharanya Chandrasekhar    646-962-3110    shc2043@med.cornell.edu   
Contact: Pragya Yadav    6469622196    pry2003@med.cornell.edu   
Principal Investigator: Timothy McClure, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Timothy McClure Weill Medical College of Cornell University
Publications:
NCCN Clinical Practice Guidelines in Oncology - Prostate Cancer (Version 2.2017). (2017)

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT05345444    
Other Study ID Numbers: 22-03024562
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Weill Medical College of Cornell University:
Irreversible Electroporation
Radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases