Prostate Cancer
Conditions
Keywords
Prostate Cancer, Prostate Tissue, NanoKnife System, Focal Therapy, Intermediate-Risk, Irreversible Electroporation (IRE)
Brief summary
Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Interventions
DEVICEIrreversible 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.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is greater than 50 years of age 2. Has at least a 10-year life expectancy 3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c 4. Has a PSA ≤ 15 ng/mL or PSA density \< 0.2 ng/mL2 if PSA is \> 15 ng/mL 5. Has Gleason score 3+4 or 4+3 6. Has no evidence of extraprostatic extension by mpMRI 7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy 8. Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation 9. Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion in the area of the MR-visible lesion 10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy) 11. Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject 12. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Exclusion criteria
1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium 2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis 3. Has an active urinary tract infection (UTI) 4. Has a history of bladder neck contracture 5. Is interested in future fertility 6. Has a history (within 3 years) of inflammatory bowel disease 7. Has a concurrent major debilitating illness 8. Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer 9. Has any active implanted electronic device (e.g., pacemaker) 10. Is unable to catheterize due to a urethral stricture disease 11. Has 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 5. Surgery for prostate cancer 12. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants 13. Has had prior major rectal surgery (except hemorrhoids) 14. Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI)) 15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder 16. Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons 17. In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Negative In-field Biopsy at 12 Months | 12 months | Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months |
| Number of Participants With Device-related Adverse Events Through 12 Months | 12 months | Number of participants who experienced any adverse event related to the study device during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion | 12 months | 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) |
| Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite | 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 |
| Assessment of Erectile Function by Comparison of Pre- and Post-operative IIEF-15 Potency Scores | 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) |
| Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics | 12 months | Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, including PSA nadir |
| Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline | 12 months | Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, percent change from baseline |
| Assessment of Changes in Prostate Volume | 12 months | Assessment of percent change in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI. |
| Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI | 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. |
| Assessment of Need for Secondary or Adjuvant Treatment | 12 months | Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System. |
| Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Coleman, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL_INVESTIGATORArvin George, MD
University of Michigan
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.6 Years STANDARD_DEVIATION 7.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 100 Participants |
| Region of Enrollment United States | 121 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 121 |
| other Total, other adverse events | 100 / 121 |
| serious Total, serious adverse events | 11 / 121 |
Outcome results
None listed