Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low Risk Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01972867|
Recruitment Status : Withdrawn
First Posted : October 31, 2013
Last Update Posted : February 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: NanoKnife Procedure||Not Applicable|
This study is designed to be a prospective, non-randomized pilot study in 6 subjects treated at up to three (3) clinical sites. This study will involve six (6) subjects who meet the low risk prostate cancer criteria defined by this protocol. The subjects' prostate cancer foci, the location of which will be determined by ultrasound guided transperineal 3-Dimensional Prostate Mapping Biopsy (3D-PMB), will be targeted for treatment with the NanoKnife System. The primary objective of this portion of the study will be to evaluate procedural and short-term post treatment safety of the NanoKnife treatment via incidence of adverse events and evaluation of effect on urologic (urinary and erectile) function. The secondary objective of this study is to evaluate the short term efficacy of the NanoKnife treatment. Local efficacy in the area of treatment will be assessed via histological evaluation of 3D-PMB cores obtained throughout the half of the prostate where treatment was targeted at three (3) months post NanoKnife treatment, to evaluate the ablation zone created by the NanoKnife treatment. Following the 3 month biopsy assessment the data from these 6 subjects will be submitted to FDA for confirmation of short term safety and efficacy.
This group of subjects will continue to be followed for safety and efficacy for 2 years. Safety will be assessed via incidence of adverse events and evaluation of effect on urologic function and quality of life. Local efficacy will be characterized via MR imaging and evaluated via post treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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 Risk Patient Population|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: NanoKnife Procedure
The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.
Device: NanoKnife Procedure
Under general anesthesia and with paralytic on board, patients will have monopolar probes inserted bracketing the tumor. A total of 90 electrical pulses will be delivered to irreversibly electroporate the tissue.
Other Name: NanoKnife (Model HVP01)
- Safety [ Time Frame: 3 months post procedure ]
To determine safety by evaluating AE incidence, type, duration, severity and relationship to study device.
Determine morbidity profile by evaluating urinary and erectile function
- Procedural Effects [ Time Frame: 2 Years ]
- To determine completeness of ablation in the targeted prostate cancer tissue as 3D-PMB at 3 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972867
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|