Prostatic Neoplasms
Conditions
Keywords
irreversible electroporation, Unresectable Prostatic Neoplasms
Brief summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Prostatic Neoplasms.
Detailed description
By enrolling patients with unresectable Prostatic Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Prostatic Neoplasms.
Interventions
PROCEDUREIrreversible electroporation (IRE)
DEVICENanoKnife
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Prostatic Neoplasms diagnosed by positive biopsy or non-invasive criteria, * Not suitable for surgical resection, * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * A prothrombin time ratio \> 50%, * Platelet count \> 80x10\^9/L, * Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * Able to comprehend and willing to sign the written informed consent form (ICF), * Have a life expectancy of at least 3 months.
Exclusion criteria
* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * Any active implanted device (eg Pacemaker), * Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse events | 6 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of lesions that show no sign of recurrence 12 months after IRE | 12 months | — |
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) | 3 months | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. |
| Progress free disease (PFS) | 12 months | — |
| Overall survival (OS) | 36 months | Patients will be followed for 36 months after IRE for OS analyzed. |
Countries
China
Outcome results
None listed