Clinical trial NCT05512663: Safety and Efficacy Evaluation of Transperineal Irreversible Electroporation (IRE) of Anterior Prostate Cancer
Official title: A Pilot Study Evaluating Safety and Efficacy of Transperineal Focal Irreversible Electroporation (IRE) of Anterior Prostate Cancer in Patients With an Intermediate Risk.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Intermediate Risk Prostate Cancer
Irreversible Electroporation (IRE)
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: The occurrence of possible Adverse Events
timeFrame: From the operation date until the end of the study (12 months)
measure: Analysis of Urinary function by UCLA-EPIC scores #1.1
timeFrame: At Screening (Pre-operative)
measure: Analysis of Urinary function by UCLA-EPIC scores #1.2
timeFrame: At 1-month post-operation
measure: Analysis of Urinary function by UCLA-EPIC scores #1.3
timeFrame: At 3-month post-operation
measure: Analysis of Urinary function by UCLA-EPIC scores #1.4
timeFrame: At 6-month post-operation
measure: Analysis of Urinary function by UCLA-EPIC scores #1.5
timeFrame: At 9-month post-operation
measure: Analysis of Urinary function by UCLA-EPIC scores #1.6
timeFrame: At 12-month post-operation
measure: Analysis of Urinary function by IPSS-QoL scores #2.1
timeFrame: At Screening (Pre-operative)
measure: Analysis of Urinary function by IPSS-QoL scores #2.2
timeFrame: At 1-month post-operation
measure: Analysis of Urinary function by IPSS-QoL scores #2.3
timeFrame: At 3-month post-operation
measure: Analysis of Urinary function by IPSS-QoL scores #2.4
timeFrame: At 6-month post-operation
measure: Analysis of Urinary function by IPSS-QoL scores #2.5
timeFrame: At 9-month post-operation
measure: Analysis of Urinary function by IPSS-QoL scores #2.6
timeFrame: At 12-month post-operation
measure: Analysis of Erectile function by IIEF-15 scores #1.1
timeFrame: At Screening (Pre-operative)
measure: Analysis of Erectile function by IIEF-15 scores #1.2
timeFrame: At 1-month post-operation
measure: Analysis of Erectile function by IIEF-15 scores #1.3
timeFrame: At 3-month post-operation
measure: Analysis of Erectile function by IIEF-15 scores #1.4
timeFrame: At 6-month post-operation
measure: Analysis of Erectile function by IIEF-15 scores #1.5
timeFrame: At 9-month post-operation
measure: Analysis of Erectile function by IIEF-15 scores #1.6
timeFrame: At 12-month post-operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: