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To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irreversible Electroporation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible Electroporation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile | Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Side Effects | • Change in erectile function measured by the IIEF-15 questionnaire | Up to 1 year |
| Continence side effect | • Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Role of follow-up MRI | • Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test | Six months |
| Anxiety | • Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hashim U Ahmed, PhD | UCLH | Principal Investigator |
| Mark Emberton, Professor | UCLH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospitals | London | NW1 2PG | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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| Up to 1 year |
| Rectal side effects | • Number of patients with grade I-II-III type rectal toxicity | Up to 1 year |
| Cancer Control | Number of patients having residual prostate cancer at 6 months biopsy | Six months |
| Up to 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |