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Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low Risk Patients

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ClinicalTrials.gov Identifier: NCT01972867
Recruitment Status : Withdrawn
First Posted : October 31, 2013
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE October 31, 2013
Last Update Posted Date February 11, 2016
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01972867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Procedural Effects [ Time Frame: 2 Years ]
Secondary Objectives
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low Risk Patients
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife™ System when used to ablate localized prostate cancer in low risk subjects with organ-confined prostate cancer and a low risk of recurrence. This study will evaluate the feasibility of the NanoKnife™ System as a focal therapy.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: NanoKnife Procedure
The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.
Intervention: Device: NanoKnife Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 10, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2013)
6
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ages 50-70 years,
  2. Have histologically confirmed organ-confined prostate cancer - Clinical Stage T1 or T2a,
  3. Have a PSA less than 10 ng/mL,
  4. Have a PSA density less than 0.15 ng/ml/cc,
  5. Have a PSA velocity less than 2 ng/ml yearly in the year prior to diagnosis,
  6. Has no Gleason grade 4 or 5,
  7. Has a single lesion with a maximum size of ≤ 12 mm with ≤ 10 mm of capsular contact as confirmed by MR imaging,
  8. Has ≤20% of cancer in any biopsy core,
  9. Has ≤ 7 mm of cancer in any biopsy core,
  10. Has ≤ 33% positive biopsy cores
  11. No evidence of extraprostatic extension or seminal vesicle invasion by MRI,
  12. Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation,
  13. Has no prostate calcification greater than 5 mm in the treatment zone, as noted by TRUS,
  14. Has the ability to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post procedure,
  15. Must sign a written informed consent,
  16. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits.

Exclusion Criteria:

  1. Have known hypersensitivity to pancuronium bromide, atracurium or cisatracurium,
  2. Have known hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobial agents,
  3. Have anesthesia surgical assignment category IV or greater,
  4. Have a bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140,000 platelets per microliter of circulating blood1
  5. Have an active urinary tract infection (UTI),
  6. Have a history of bladder neck contracture,
  7. Are interested in future fertility,
  8. Have a history (within 3 years) of inflammatory bowel disease,
  9. Have a concurrent major debilitating illness,
  10. Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years,
  11. Have any active implanted electronic device (e.g., pacemaker),
  12. Are unable to catheterize due to a urethral stricture disease,
  13. Have had prior or current prostate cancer therapies:

    1. Biologic therapy for prostate cancer
    2. Chemotherapy for prostate cancer
    3. Hormonal therapy for prostate cancer within three months of procedure,
    4. Radiotherapy for prostate cancer,
  14. Have had prior transurethral prostatectomy (TURP), or urethral stent,
  15. Have had prior major rectal surgery (except hemorrhoids).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972867
Other Study ID Numbers  ICMJE ON-NK310
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angiodynamics, Inc.
Study Sponsor  ICMJE Angiodynamics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Angiodynamics, Inc.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP