Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low and Intermediate Risk Patients
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|ClinicalTrials.gov Identifier: NCT01972867|
Recruitment Status : Not yet recruiting
First Posted : October 31, 2013
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: NanoKnife Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in a Low and Intermediate Risk Patient Population|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2022|
Experimental: NanoKnife Procedure
The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.
Device: NanoKnife Procedure
Subjects will be placed in the dorsal lithotomy position, under sterile technique. The NanoKnife procedure will be carried out under general anesthesia. A Foley catheter will be placed to aid in draining the bladder during treatment.
Other Name: NanoKnife
- Safety [ Time Frame: 6 months ]To determine the NanoKnife treatment procedural and short-term post-treatment safety profile by evaluating adverse event incidence, type, duration, severity and relationship to study device.
- Treatment Morbidity Profile [ Time Frame: 6 months ]Determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.
- Completeness of Ablation [ Time Frame: 6 months ]
To determine completeness of ablation in the targeted prostate cancer tissue, in relation to probe placement and treatment parameters applied, as determined by histological evaluation of transperineal prostate biopsy cores at six (6) months post- treatment.
- Determine post-treatment PSA kinetics
- Determine effectiveness of therapy by post-treatment imaging (necrosis, presence of residual tissue)
- Determine effectiveness of therapy by rates of biochemical and clinical progression; need for secondary or adjuvant treatment
- Prostate-Specific Antigen Kinetics [ Time Frame: 24 months ]Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.
- Effectiveness of Therapy [ Time Frame: 24 months ]To determine the effectiveness of therapy by post-treatment early-contrast MRI and multiparametric magnetic resonance imaging (mpMRI) to evaluate the area of necrosis and presence of residual tissue.
- Effectiveness of Therapy [ Time Frame: 24 months ]To determine the effectiveness of therapy by recording the rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following therapy.
- Health-Related Quality of Life [ Time Frame: 24 months ]To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.