Trial Outcomes & Findings for Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (NCT NCT04972097)
NCT ID: NCT04972097
Last Updated: 2026-06-02
Results Overview
Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
12 months
Results posted on
2026-06-02
Participant Flow
Participant milestones
| Measure |
NanoKnife System
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
|
|---|---|
|
Overall Study
STARTED
|
121
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
NanoKnife System
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
Baseline characteristics by cohort
| Measure |
IRE Treatment Arm
n=121 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Age, Continuous
|
66.6 Years
STANDARD_DEVIATION 7.16 • n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: ITT Population, n=14 subjects with missing biopsy information at 12 months were imputed as positive.
Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months
Outcome measures
| Measure |
IRE Treatment Arm
n=121 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Number of Participants With a Negative In-field Biopsy at 12 Months
Negative In-Field Biopsy
|
86 Participants
|
|
Number of Participants With a Negative In-field Biopsy at 12 Months
Positive In-Field Biopsy
|
35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: ITT Population
Number of participants who experienced any adverse event related to the study device during the study
Outcome measures
| Measure |
IRE Treatment Arm
n=121 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Number of Participants With Device-related Adverse Events Through 12 Months
Experienced any device-related adverse event
|
84 Participants
|
|
Number of Participants With Device-related Adverse Events Through 12 Months
Experienced no device-related adverse events
|
37 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT, including subjects with biopsy data available at 12 months or who had a positive in-field biopsy prior to 12 months (i.e., no imputation performed for subjects missing biopsy information post-treatment)
Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months, as defined by the Delphi consensus criterion of absence of clinically significant disease (where ≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is considered insignificant)
Outcome measures
| Measure |
IRE Treatment Arm
n=106 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion
Negative In-Field Biopsy (Delphi Consensus)
|
89 Participants
|
|
Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion
Positive In-Field Biopsy (Delphi Consensus)
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available scores (completed questionnaire) at baseline and at 12 months
Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain (range from 0-100 with higher scores representing better quality of life) and International Prostate Symptom Scores (IPSS) (range from 0 to 35 (asymptomatic to very symptomatic)) and IPSS Quality of Life (IPSS-QoL) scores (range from zero (0) indicating Delighted to six (6) indicating Terrible), change from Baseline to 12 Months
Outcome measures
| Measure |
IRE Treatment Arm
n=108 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite
UCLA-EPIC Urinary Domain, change from baseline to 12 months
|
3.3 scores on a scale
Standard Deviation 10.47
|
|
Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite
International Prostate Symptom Scores (IPSS), change from baseline to 12 months
|
-2.1 scores on a scale
Standard Deviation 5.28
|
|
Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite
IPSS Quality of Life (IPSS-QoL), change from baseline to 12 months
|
-0.6 scores on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available scores (completed questionnaire) at baseline and at 12 months
Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores, change from Baseline to 12 Months (range 0 - 75, higher scores indicate less dysfunction/higher satisfaction)
Outcome measures
| Measure |
IRE Treatment Arm
n=99 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Assessment of Erectile Function by Comparison of Pre- and Post-operative IIEF-15 Potency Scores
|
-5.3 scores on a scale
Standard Deviation 15.91
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available PSA at baseline and at 12 months
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, including PSA nadir
Outcome measures
| Measure |
IRE Treatment Arm
n=105 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics
Change in PSA from baseline to 12 Months
|
-3.4 ng/mL
Interval -5.3 to -2.1
|
|
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics
PSA Nadir
|
1.3 ng/mL
Interval 0.8 to 2.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available PSA at baseline and at 12 months
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, percent change from baseline
Outcome measures
| Measure |
IRE Treatment Arm
n=105 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline
|
-59.8 % change
Interval -77.8 to -44.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available prostate volume at baseline and at 12 months
Assessment of percent change in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.
Outcome measures
| Measure |
IRE Treatment Arm
n=110 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Assessment of Changes in Prostate Volume
|
-15.9 % change
Standard Deviation 20.54
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available MRI imaging at baseline and at 12 months
Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 12 months post-treatment, using the PI-RADS scoring system, a 1-to-5 scale used on prostate MRI to indicate the likelihood of clinically significant prostate cancer, with higher scores suggesting greater suspicion of cancer.
Outcome measures
| Measure |
IRE Treatment Arm
n=110 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI
PI-RADS 3 or Higher Lesion at 12 Months
|
18 Participants
|
|
Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI
PI-RADS 1 or 2 or no Lesions at 12 Months
|
92 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population
Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System.
Outcome measures
| Measure |
IRE Treatment Arm
n=121 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Assessment of Need for Secondary or Adjuvant Treatment
Re-treated with NanoKnife
|
1 Participants
|
|
Assessment of Need for Secondary or Adjuvant Treatment
Not Re-treated with NanoKnife
|
120 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population, patients with available scores (completed questionnaire) at baseline and at 12 months
Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQoL (EQ-5D®) EQ VAS. Scale ranges from minimum of 0 (worse) to 100 (better/best).
Outcome measures
| Measure |
IRE Treatment Arm
n=109 Participants
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months
|
0.3 score on a scale, change from baseline
Standard Deviation 9.31
|
Adverse Events
IRE Treatment Arm
Serious events: 11 serious events
Other events: 100 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
IRE Treatment Arm
n=121 participants at risk
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Renal and urinary disorders
Haematuria
|
1.7%
2/121 • Number of events 2 • 12 Months
|
|
Renal and urinary disorders
Bladder spasm
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Renal and urinary disorders
Urinary retention
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Infections and infestations
Pneumonia
|
1.7%
2/121 • Number of events 2 • 12 Months
|
|
Infections and infestations
Diverticulitis
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
General disorders
Disease progression
|
1.7%
2/121 • Number of events 2 • 12 Months
|
|
General disorders
Pyrexia
|
0.83%
1/121 • Number of events 2 • 12 Months
|
|
General disorders
Chills
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Gastrointestinal disorders
Rectourethral fistula
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Investigations
Biopsy bladder
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
1/121 • Number of events 1 • 12 Months
|
|
Vascular disorders
Deep vein thrombosis
|
0.83%
1/121 • Number of events 1 • 12 Months
|
Other adverse events
| Measure |
IRE Treatment Arm
n=121 participants at risk
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation: IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
|
|---|---|
|
Renal and urinary disorders
Haematuria
|
42.1%
51/121 • Number of events 57 • 12 Months
|
|
Renal and urinary disorders
Dysuria
|
15.7%
19/121 • Number of events 20 • 12 Months
|
|
Renal and urinary disorders
Urinary retention
|
14.9%
18/121 • Number of events 20 • 12 Months
|
|
Renal and urinary disorders
Micturition urgency
|
14.0%
17/121 • Number of events 18 • 12 Months
|
|
Renal and urinary disorders
Pollakiuria
|
12.4%
15/121 • Number of events 17 • 12 Months
|
|
Renal and urinary disorders
Bladder spasm
|
8.3%
10/121 • Number of events 10 • 12 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
5.8%
7/121 • Number of events 8 • 12 Months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
18.2%
22/121 • Number of events 24 • 12 Months
|
|
Reproductive system and breast disorders
Haematospermia
|
12.4%
15/121 • Number of events 16 • 12 Months
|
|
Reproductive system and breast disorders
Penile pain
|
5.0%
6/121 • Number of events 6 • 12 Months
|
|
Gastrointestinal disorders
Constipation
|
5.0%
6/121 • Number of events 6 • 12 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
6/121 • Number of events 6 • 12 Months
|
|
General disorders
Fatigue
|
5.0%
6/121 • Number of events 6 • 12 Months
|
|
Infections and infestations
Urinary tract infection
|
5.8%
7/121 • Number of events 10 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place