Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000859684
Ethics application status
Approved
Date submitted
12/07/2023
Date registered
9/08/2023
Date last updated
9/08/2023
Date data sharing statement initially provided
9/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-Centre Registry to assess clinical and quality of life outcomes in patients under going the Irreversible Electroporation (more commonly know as NanoKnife) procedure
Scientific title
Multi-Centre Registry for Oncological and Quality of Life Outcomes of Irreversible Electroporation (IRE) of Prostate Cancer
Secondary ID [1] 310107 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 330675 0
Condition category
Condition code
Cancer 327488 327488 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
This is a prospective observational multi-centre registry in which clinical data on consecutive patients with prostate cancer who undergo IRE procedure is collected. Data from site medical records as part of standard of care will be collected at each participating site over a 10-year period. Patients’ data to include, baseline visit (pre-IRE), peri-operative data and follow up for 10 years will be recorded.

Follow up data at each participating treatment site is collected according to the guidelines for focal therapy in prostate cancer and/or by discretion of each treating Urologist. Amendments to the standard of care are not required nor desirable. Deviation from current practices will be by the discretion of the treating urologist only and outcomes will be included in this registry as it is purely observational in nature.
Intervention code [1] 326503 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335354 0
To assess oncological outcomes defined by recurrence of prostate cancer at 1,3, 5, and 10 years after IRE.
Timepoint [1] 335354 0
Assessed by analysing data from MRI, PSMA PET scans and histopathology reports conducted as part of standard of care at 1,3, 5, and 10 years after IRE.
Secondary outcome [1] 424901 0
To assess change in functional outcomes post IRE
Timepoint [1] 424901 0
Assessed by analysing data from Epic questionnaire prior to IRE (baseline) and post IRE (6 wks, 3, 6, 12, 24, 36, 48, 60 months)

Eligibility
Key inclusion criteria
Patient 18 years and above
Is diagnosed with histologically confirmed prostate cancer
Is scheduled for IRE Nanoknife® regardless of previous treatments
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No specific exclusion criteria are defined.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All clinico-pathological and procedural variables will be described and analyzed. Continuous variables will be summarized with standard descriptive statistics including means, standard deviations, medians and ranges. Categorical variables will be summarized with frequencies. Univariate survival and disease free survival analyses will be performed using the Kaplan-Meier method.

For comparison of index tests to follow-up treatment response (mpMRI/PSMA-PET) and reference test (template biopsies) a 2x2 contingency table will be used to calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ROI on imaging. Multivariate linear regression analyses will be performed to evaluate the additional value of NADIR PSA (absolute value and density) to detect residual infield/outfield PCA. Statistical tests will be performed using SPSS/R/Graphpad and P<0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 25126 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 25127 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 25128 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 40793 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 40794 0
3144 - Malvern
Recruitment postcode(s) [3] 40795 0
4066 - Auchenflower
Recruitment outside Australia
Country [1] 25635 0
Israel
State/province [1] 25635 0
Tel Aviv,
Country [2] 25636 0
New Zealand
State/province [2] 25636 0
Rotorua

Funding & Sponsors
Funding source category [1] 314267 0
Commercial sector/Industry
Name [1] 314267 0
Angiodynamics Inc
Country [1] 314267 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Private Hospital
Address
406 Victoria Street Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 316206 0
None
Name [1] 316206 0
Address [1] 316206 0
Country [1] 316206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313386 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 313386 0
St Vincent’s Hospital Sydney Research Office
St Vincent’s Health Network
Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 313386 0
Australia
Date submitted for ethics approval [1] 313386 0
Approval date [1] 313386 0
19/12/2022
Ethics approval number [1] 313386 0
2022/ETH01674

Summary
Brief summary
This is a prospective observational multi-centre registry in which clinical data on consecutive patients with prostate cancer who undergo irreversible electroporation (IRE) procedure is collected.

Who is it for?
You may be eligible to join this study if you have been diagnosed with histologically confirmed prostate cancer and are scheduled for IRE Nanoknife procedure.

Study details
Patients with prostate cancer who undergo IRE procedure at participating clinics will have their medical data collected and collated into this clinical registry. Patients’ data to include baseline visit (pre-IRE) and peri-operative data.

Participants will then be followed-up at 1, 3, 5, and 10 years after IRE to determine oncological and functional outcomes. Follow up data at each participating treatment site is collected according to the guidelines for focal therapy in prostate cancer and/or by discretion of each treating Urologist. Amendments to the standard of care are not required nor desirable. Deviation from current practices will be by the discretion of the treating urologist only and outcomes will be included in this registry as it is purely observational in nature.

It is hoped that this research project will provide a better understanding of patient outcomes undergoing IRE procedure. .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127970 0
Prof Phillip Stricker
Address 127970 0
St Vincent's Clinic
Level 10/438 Victoria St, Darlinghurst NSW 2010
Country 127970 0
Australia
Phone 127970 0
+61 2 8382 6971
Fax 127970 0
Email 127970 0
phillip@stricker.com.au
Contact person for public queries
Name 127971 0
Mrs Shikha Agrawal
Address 127971 0
The KingHorn Cancer Centre
370 Victoria St, Darlinghurst NSW 2010
Country 127971 0
Australia
Phone 127971 0
+61 402901143
Fax 127971 0
Email 127971 0
s.agrawal@garvan.org.au
Contact person for scientific queries
Name 127972 0
Prof Phillip Stricker
Address 127972 0
St Vincent's Clinic
Level 10/438 Victoria St, Darlinghurst NSW 2010
Country 127972 0
Australia
Phone 127972 0
+61 2 8382 6971
Fax 127972 0
Email 127972 0
phillip@stricker.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.