Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451445
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-29
Brief Title:
A Pan-Canadian Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Pan-Canadian Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer The WIRED Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WIRED
Brief Summary:
The goal of this clinical trial is to investigate the safety and efficacy of Irreversible Electroporation IRE using NanoKnife technology in patients with intermediate-risk prostate cancer This patient population was chosen because they would otherwise be treated with conventional therapies with high side effects The main questions it aims to answer are
1 Is the NanoKnife system is effective at damaging prostate tumour cells and killing the cancer
2 Are there any safety concerns with the procedure or major side effects caused by the treatment
Participants will undergo IRE treatment with the NanoKnife system and then complete follow-up appointments for 12-months after the procedure
1 Is the NanoKnife system is effective at damaging prostate tumour cells and killing the cancer
2 Are there any safety concerns with the procedure or major side effects caused by the treatment
Participants will undergo IRE treatment with the NanoKnife system and then complete follow-up appointments for 12-months after the procedure
Detailed Description:
Study Population This study is being conducted with intermediate-risk prostate cancer patients Gleason score 7 This patient population was chosen because they would otherwise be treated with conventional therapies RP or RT which are often associated with significant side effects
Study Design This study is designed to be a prospective non-randomized study in 100 subjects treated at up to 5 clinical sites in Canada
Prospective study subjects who sign a written informed consent will be enrolled in the study Study eligibility will be confirmed at the Screening visit Transperineal or transrectal prostate biopsy must have been performed no more than 180 days prior to the time of consent mpMRI must have been within 360 days prior to treatment If they continue to meet enrollment criteria they will be scheduled for treatment and after undergoing standard bowel preparation the NanoKnife System procedure will be carried out under general anesthesia and utilizing transrectal ultrasound US guidance
Subjects will undergo treatment with the NanoKnife System as well as follow-up visits at 1 3 6 9 and 12 months post-procedure Transrectal US and transperineal or transrectal biopsy will be completed at the 12-month follow up visit Post-treatment imaging will be completed using mpMRI scan at 9-12 months post-procedure
Study Agent Intervention Procedure The intervention being studied is Irreversible Electroporation IRE using NanoKnife technology This technology uses high voltage current via probes placed around the prostate tumour via the perineum The electricity damages the cell membranes rendering the cells dead Hypothesized benefits of IRE over other focal therapy options include the ability to treat large or small lesions Also because the technology spares vessels it can be used to treat prostate areas adjacent to sensitive structures ie prostate apex near the sphincter and lateral peripheral zone near the neurovascular bundle Finally treatments take approximately 1-15 hours thus the technology could be used to treat several patients per day
Primary Objectives
1 To determine the NanoKnife Systems ablation effectiveness and durability by measuring the negative in-field biopsy rate at 12 months
2 To determine the NanoKnife Systems procedural and post-procedural safety profile by evaluating adverse event incidence type and severity through 12 months
Secondary Objectives
1 To evaluate whether clinically significant prostate cancer will develop outside the ablation zone in men selected for focal IRE therapy as determined by positive prostate biopsy outside the ablation zone 12 months post treatment
2 To evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires UCLA-EPIC IPSS IPSS-QOL IIEF-15
3 To determine post-NanoKnife System treatment prostate-specific antigen PSA kinetics including time to PSA nadir and post-nadir PSA stability
4 To determine the effectiveness of therapy by assessing the need for secondary or salvage treatment following therapy
5 To determine health-related quality of life HRQoL levels after treatment with the NanoKnife System using a validated subject questionnaire EQ-5D
Exploratory Objective
1 To evaluate longer term effectiveness of focal IRE and possible delayed adverse events through 5-years
Study Design This study is designed to be a prospective non-randomized study in 100 subjects treated at up to 5 clinical sites in Canada
Prospective study subjects who sign a written informed consent will be enrolled in the study Study eligibility will be confirmed at the Screening visit Transperineal or transrectal prostate biopsy must have been performed no more than 180 days prior to the time of consent mpMRI must have been within 360 days prior to treatment If they continue to meet enrollment criteria they will be scheduled for treatment and after undergoing standard bowel preparation the NanoKnife System procedure will be carried out under general anesthesia and utilizing transrectal ultrasound US guidance
Subjects will undergo treatment with the NanoKnife System as well as follow-up visits at 1 3 6 9 and 12 months post-procedure Transrectal US and transperineal or transrectal biopsy will be completed at the 12-month follow up visit Post-treatment imaging will be completed using mpMRI scan at 9-12 months post-procedure
Study Agent Intervention Procedure The intervention being studied is Irreversible Electroporation IRE using NanoKnife technology This technology uses high voltage current via probes placed around the prostate tumour via the perineum The electricity damages the cell membranes rendering the cells dead Hypothesized benefits of IRE over other focal therapy options include the ability to treat large or small lesions Also because the technology spares vessels it can be used to treat prostate areas adjacent to sensitive structures ie prostate apex near the sphincter and lateral peripheral zone near the neurovascular bundle Finally treatments take approximately 1-15 hours thus the technology could be used to treat several patients per day
Primary Objectives
1 To determine the NanoKnife Systems ablation effectiveness and durability by measuring the negative in-field biopsy rate at 12 months
2 To determine the NanoKnife Systems procedural and post-procedural safety profile by evaluating adverse event incidence type and severity through 12 months
Secondary Objectives
1 To evaluate whether clinically significant prostate cancer will develop outside the ablation zone in men selected for focal IRE therapy as determined by positive prostate biopsy outside the ablation zone 12 months post treatment
2 To evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires UCLA-EPIC IPSS IPSS-QOL IIEF-15
3 To determine post-NanoKnife System treatment prostate-specific antigen PSA kinetics including time to PSA nadir and post-nadir PSA stability
4 To determine the effectiveness of therapy by assessing the need for secondary or salvage treatment following therapy
5 To determine health-related quality of life HRQoL levels after treatment with the NanoKnife System using a validated subject questionnaire EQ-5D
Exploratory Objective
1 To evaluate longer term effectiveness of focal IRE and possible delayed adverse events through 5-years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None