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Trial Title:
Safety and Efficacy Evaluation of Transperineal Irreversible Electroporation (IRE) of Anterior Prostate Cancer
NCT ID:
NCT05512663
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Intermediate Risk Prostate Cancer
Irreversible Electroporation (IRE)
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Irreversible Electroporation (IRE)
Description:
The area of the prostate that was positive for cancer based on the transperineal prostate
biopsy will be targeted for ablation via the NanoKnife System. An MRI/TRUS fusion device
probe will be placed in the rectum and the prostate will be visualized in both sagittal
and axial views. The ultrasound grid which was used during the mapping biopsy will be
oriented using anatomical landmarks and used to identify the location of the positive
biopsy cores. The NanoKnife Single Electrode Probes will be surgically inserted into the
prostate through the perineum using MRI/TRUS fusion guidance and the ultrasound grid for
guidance.
Arm group label:
Irreversible Electroporation (IRE) treatment
Summary:
Most prostate cancer treatment research in the last decade has been focused on trying to
improve quality of life, while maintaining a high level of cancer control. However, the
concept of Focal treatment is proposed as an intermediate option between active
surveillance and treatment of the whole prostate. Focal ablation aims to efficiently
treat the localized cancer while reducing complications related to standard treatments,
including the risks of incontinence and impotence.
Focal Irreversible Electroporation (IRE) delivered by NanoKnife System is composed of the
NanoKnife Generator and NanoKnife Single Electrode Probes. With IRE, an electrical
current is delivered between a pair of probes in a series of pulses. These pulses create
irreversible pores in cell membranes and lead to cell death which allow for only the
tissue between these probes being destroyed.
The aim of this study is to analyze the safety and efficacy of transperineal IRE
treatments in intermediate risk anteriorly localized prostate cancer patients.
Detailed description:
There are different effective treatment options for intermediate risk prostate cancer to
choose from. The standard of care are definite treatments such as robotic surgery or
radiotherapy. Robotic surgeries involve the removal of the entire prostate. On the other
hand, radiotherapy is a form of treatment that is done by either an external beam at high
and low dose rate or by brachytherapy. The external beam at high or low dose rate targets
the entire prostate. Brachytherapy, which involves a special radiation source that is
placed inside the tumour, targets only specific parts of the prostate.
Both robotic surgeries and radiotherapy provide a greater certainty of cancer control
than any other treatments option, however there is a significant risk of side effects
that many follow these treatments. Among which, there is a 50% likelihood for impotence,
5-10% likelihood of incontinence and 5-20% likelihood of bowel dysfunction.
One way of reducing the unwanted side-effects from radical treatment of prostate cancer
may be to direct treatment to only areas of the cancer. This is called focal therapy,
which is the form of treatment that will be performed and observed in this study. There
has been recent research done on focal therapies that have been shown to be more
advantageous than having radical therapy or radiotherapy. Some of these advantages
include: decrease of chance or elimination of possible side-effects post-treatment, it is
a less invasive treatment option and the omission of overnight hospital stay
post-treatment, among others.
This study is designed to look at an experimental treatment of localized prostate cancer
by Focal Irreversible Electroporation (IRE) delivered by the NanoKnife System.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Has at least a 10 year life expectancy 2. Have histologically confirmed
organ-confined prostate cancer - clinical Stage T1-T2c N0M0 3. Have a PSA
<=15ng/mL 4. Has Gleason <=7 (4+3 or 3+4) 5. Has maximum cancer core length
>=4mm 6. No evidence of extraprostatic extension or seminal vesicle invasion by
mpMRI 7. Able to visualize prostate gland adequately on transrectal ultrasound
imaging during enrollment evaluation 8. Transperineal prostate biopsies
(template mapping and/or limited targeted) correlating with clinically
significant lesion in the area of the MR-visible lesion (within 2 Barzell
zones) 9. A visible lesion on mpMRI, that is accessible to IRE treatment 10.
Must sign a written informed consent 11. 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, atricurium or cisatricurium
2. Unfit for anthesthia or have a contraindication for agents listed for
paralysis 3. Have an active urinary tract infection (UTI) 4. Have a history of
bladder neck contracture 5. Are interested in future fertility 6. Have a
history (within 3 years) of inflammatory bowel disease 7. Have a concurrent
major debilitating illness 8. Had a malignancy, other than prostate or skin
cancer (except malignant melanoma), within 5 years 9. Have any active implanted
electronic device (eg, pacemaker) 10. Are unable to catheterize due to a
urethral stricture disease 11. 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
5. Surgery for prostate cancer 12. Have had prior transurethral prostatectomy
(TURP), or urethral stent 13. Have had prior major rectal surgery (except
hemorrhoids) 14. Unfit for pelvic MRI scanning (e.g. severe claustrophobia,
permanent cardiac pacemaker, metallic implant etc... likely to contribute
significant artefact to images) 15. Have a non-visible tumor on mpMRI
Gender:
Male
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Start date:
September 2022
Completion date:
September 2024
Lead sponsor:
Agency:
Jewish General Hospital
Agency class:
Other
Source:
Jewish General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512663