Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE) (NCT05345444) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
United States48 participantsStarted 2022-05-26
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
Timeframe: 12 weeks
2
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
Timeframe: 6 weeks
3
Proportion of patients who remain cancer-free
Timeframe: 12 months
Trial details
NCT IDNCT05345444
SponsorWeill Medical College of Cornell University