Table 1.
Study Procedures | Screening | IRE | Post-IRE 1-2wk FUP | Last Day RT | 3,6,9-mo FUP | 12-mo FUP | 24-mo FUP |
---|---|---|---|---|---|---|---|
Informed Consent | X | ||||||
Demographics/ MH | X | ||||||
Physical Exam | X | X | X | X | X | X | |
VS, Height, weight | X | X | X | X | X | X | |
PSA | X | X | X | X | |||
Pelvic MRI | X* | X | |||||
PSMA PET | X* | X | |||||
EPIC-CP | X | X | X | X | X | ||
IPSS | X | X | X | X | X | ||
IIEF-5 | X | X | X | X | X | ||
Tissue Biopsy (Research) | X | ||||||
Research samples (Blood, Urine) | X | X | X | ||||
Adverse Events (CTCAE v5.0) |
X | X | X | X | X | X | X |
Post-Treatment Biopsy (+/- 1 month) | X | X |
*Imaging completed ≤ 9 months acceptable for enrollment
IRE Irreversible electroporation, FUP follow up visit, mo months, MH medical history, PSMA PET prostate-specific membrane antigen positron emission tomography, EPIC-CP Expanded PCa Index Composite for Clinical Practice, IPSS International Prostate Symptom Score, CTCAE v5.0 Common Terminology Criteria for Adverse Events version 5.0