Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

Prostate Cancer Clinical Trial

— PRESERVE  

Official title:

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04972097
• Other study ID #: 2021-ONC-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Health Care	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Northshore University Healthsystem	Evanston	Illinois
United States	University of Florida Health	Gainesville	Florida
United States	Duly Health and Care	Lisle	Illinois
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Northwell Health	New York	New York
United States	NYU Langone Health	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	University of California Irvine	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of negative in-field biopsy at 12 months	To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months	12 months
Primary	Incidence of adverse events by type and CTCAE v5.0 severity through 12 months	To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months	12 months
Secondary	Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion	Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion of absence of clinically significant disease (= 3 mm of Gleason = 6 disease in any biopsy core is insignificant)	12 months
Secondary	Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite	Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain and International Prostate Symptom Scores (IPSS) and IPSS Quality of Life2 (IPSS-QoL) scores.	12 months
Secondary	Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores	Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores.	12 months
Secondary	Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics	Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir.	12 months
Secondary	Assessment of changes in prostate volume	Assessment of changes in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.	12 months
Secondary	Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI	Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 3 to 10 days post-treatment and at 12 months post-treatment.	12 months
Secondary	Assessment of need for secondary or adjuvant treatment	Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System.	12 months
Secondary	Evaluation of subject reported pre- and post-operative Quality of Life	Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQol (EQ-5D®).	12 months