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.
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.
1. Ages 50-70 years,
2. Have histologically confirmed organ-confined prostate cancer - Clinical Stage T1 or
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
13. Has no prostate calcification greater than 5 mm in the treatment zone, as noted by
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.
1. Have known hypersensitivity to pancuronium bromide, atracurium or cisatracurium,
2. Have known hypersensitivity to ciprofloxacin or any member of the quinolone class of
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).