Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-99 years
Phase:
NA
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 investig...
Detailed Description
The primary objective is to determine feasibility of combining IRE and SBRT. Feasibility is defined at 80% of subjects assessed at 12 weeks post-IRE/6 weeks post-MRgRT within 1 year from first subject...
Eligibility Criteria
Inclusion
- Men aged ≥ 18
- ECOG 0 - 1
- Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
- Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
- Gland size \< 80 cc
- Ability to undergo IRE
- Ability to receive MRI-guided radiotherapy.
- Ability to complete the HRQOL assessment surveys
- Willingness to undergo 12 month follow up biopsy
Exclusion
- Prior history of focal therapy.
- Prior history of receiving pelvic radiotherapy.
- Patient with metastatic prostate cancer.
- Patient with history of inflammatory bowel disease.
- Inability to undergo general anesthesia
- Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
- 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.
- History of bladder neck or urethral stricture.
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05345444
Start Date
May 26 2022
End Date
April 1 2027
Last Update
June 18 2025
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10065