Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001287325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/08/2026
Date registered
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27/10/2026
Date last updated
Help: Date last updated
27/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/10/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Clinical registry of focal irreversible electroporation in men with biopsy confirmed low-intermediate risk prostate cancer
Scientific title
Clinical registry of focal irreversible electroporation in men with biopsy confirmed low-intermediate risk prostate cancer
Additional trial identifiers [1] 317860 0
Nil
Universal Trial Number (UTN)
Trial acronym
FIREFLY Clinical Registry
Related trial records

Health condition
Health condition(s) studied:
Prostate Cancer 342781 0
Condition category
Condition code
Cancer 338913 338913 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of the intervention or exposure
Participants in this research registry will be recruited from the population of men receiving focal irreversible electroporation (IRE) for low to intermediate risk prostate cancer as part of clinical care as approved by local clinical governance. Participants will be followed up at regular intervals with their clinical data and Patient Reported Outcome Measures (PROMs) collected.

Multiparametric-Magnetic resonance imaging (mp-MRI) or Prostate-specific membrane antigen Positron emission tomography (PSMA PET) - Pre-treatment and again at 18 to 36 months at the discretion of the treating physician. Part of routine assessment.
Template prostate mapping (TPM) biopsy - Pre-treatment and again at 18 to 36 months at the discretion of the treating physician. Part of routine assessment.
Assess eligibility criteria - pre-treatment
Review medical history - pre-treatment
Review medications - pre-treatment
Clinical assessment - pre-treatment and every visit up to 5 years
Informed consent - pre-treatment
Prostate specific antigen (PSA) Assessment - pre-treatment and every visit up to 5 years
Focal IRE
Acute toxicities - pre-treatment and again 6 weeks, and 3 months after treatment
Late toxicities - 6, 9, 12, 15, 18, 21 and 24 months after treatment then every 6 months up to 5 years
Questionnaires - pre-treatment, 6 weeks, then 3 monthly (excluding month 15) until 5 years. PROMs are: International prostate symptom score (IPSS), Expanded prostate cancer index composite bowel assessment (EPIC), International index of erectile function (IIEF-5), Functional assessment of cancer therapy general 7 item (FACT-G7).

Enrolment is projected to be completed in 60 months after opening. The follow-up period will be completed at up to 60 months after the last participant has been enrolled.

If patient meets progression, the following will be completed;
mp-MRI (T1/2, DWI, DCE) or PSMA PET
TPM biopsy
Clinical assessment
PSA Assessment
Intervention code [1] 334687 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346139 0
Local disease control - defined as the percentage of participants who report negative or clinically insignificant disease following repeat mp-MRI and Template Prostate Mapping (TPM) biopsy.
Timepoint [1] 346139 0
This endpoint will be assessed at 18 to 36 months after Focal IRE, or upon biochemical progression, whichever is earlier. Multi-parametric MRI fusion template prostate mapping (TPM) biopsy at this timepoint is standard following focal IRE for PCa.
Primary outcome [2] 346140 0
Biochemical progression free survival at 5 years - defined as an increase in PSA greater than or equal to 2ng/mL above the nadir in which the PSA velocity following the nadir was greater than 0.75ng/mL per year.
Timepoint [2] 346140 0
6 weeks post focal IRE, then at three-monthly intervals to 24 months then at six-monthly intervals to 5 years or upon withdrawal or pathological or biochemical failure.
Secondary outcome [1] 464755 0
Treatment related toxicity (assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0).
Timepoint [1] 464755 0
6 weeks post focal IRE then at three-monthly intervals to 24 months, then at six-monthly intervals to 5 years.
Secondary outcome [2] 464756 0
Patient-reported Quality of Life as measured by the FACT-G7.
Timepoint [2] 464756 0
6 weeks post focal IRE, then at six-monthly intervals to 5 years.
Secondary outcome [3] 464757 0
Biochemical progression free survival at 3 years - defined as an increase in PSA greater than or equal to 2ng/mL above the nadir in which the PSA velocity following the nadir was greater than 0.75ng/mL per year.
Timepoint [3] 464757 0
6 weeks post focal IRE , then at three-monthly intervals to 24 months then at six-monthly intervals to 3 years or upon withdrawal or pathological or biochemical failure.
Secondary outcome [4] 464758 0
Patient-reported Quality of Life as measured by the IPSS
Timepoint [4] 464758 0
6 weeks post focal IRE then at six-monthly intervals to 5 years.
Secondary outcome [5] 464759 0
Patient-reported Quality of Life as measured by the IIEF
Timepoint [5] 464759 0
6 weeks post focal IRE then at six-monthly intervals to 5 years.
Secondary outcome [6] 464760 0
Patient-reported Quality of Life as measured by the EPIC bowel domain
Timepoint [6] 464760 0
6 weeks post focal IRE then at six-monthly intervals to 5 years

Eligibility
Key inclusion criteria
Patients eligible for enrolment into the FIREFLY registry are those who have had or will have focal IRE treatment and meet the following inclusion criteria:
• Men 40-85 years of age (inclusive);
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Life expectancy greater than 10 years based on co-morbidity not related to prostate cancer.
• Prostate specific antigen (PSA) level less than 15 ng/ml
• Prostate cancer clinical stage T1c or T2a
• PIRADS score of 3-5 (inclusive) or suspicious prostate lesion on Prostate Specific
Membrane Antigen Positron Emission Tomography (PSMA-PET)
• Reproducible template biopsy of the prostate gland demonstrating:
o Histologically-proven index lesion Gleason 6 ( more than 10mm in 1 core) or 7
(3+4) (any length) or 7 (4+3) (longest core less than 10mm) adenocarcinoma
coinciding with mp-MRI;
o Template biopsies of the remaining gland, with minimum 18 cores taken
o Non sector positive prostate containing no cancer or clinically
insignificant cancer (cancer core length <10mm Gleason 3+3)

• No significant urinary obstructive symptoms
• Select cases deemed suitable as per clinician discretion
• Able to participate in the stipulated follow-up (either telephone follow-up or on-site
visits acceptable, but one follow-up annually should be in person).
• Patients or their legal representatives must have the ability to read, understand
and provide written informed consent.
Minimum age
40 Years
Maximum age
85 Years
Sex
Males
Healthy volunteers
No
Key exclusion criteria
Patients who meet any of the following criteria are not eligible for focal IRE or
enrolment into the FIREFLY registry:
• Evidence orsuspicion of extra-capsular extension on MRI.
• Prostate cancer with significant sarcomatoid, ductal,spindle cell or
neuroendocrine small cell components.
• Any other active malignancy (untreated, progressive or recurrent), except for
non-melanoma skin cancer.

• Any inactive malignancy diagnosed within 5 years of entry, except for non-
melanoma skin cancer.

• Any anatomical abnormality or medical condition precluding IRE treatment, or
follow-up imaging (i.e. unable to cease anti-coagulant therapy,
contraindications to anaesthesia, imperforate anus, transurethral resection of
the prostate (TURP) defect, diffuse intra-prostatic calcification, unfavourable
prostatic geometry etc.)
• Chronic or acute prostatitis, neurogenic bladder, urinary tract infection,
sphincter abnormalities, or any other symptom that prevents normal
micturition.
• Patients who have received, or are receiving, any form of localised or systemic
treatment (including Androgen Deprivation Therapy (ADT)) for prostate
carcinoma (excluding 5a-reductase inhibitors).
• Patients who are unwilling or unable to adhere to study requirements, including
treatment and required assessments.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be reported using frequencies and percentages or proportions for binary or categorical data. Percentages will be calculated based upon the number of patients for whom data are available. Continuous or dimensional variables will be summarised using means and standard deviations, or medians and interquartile ranges (25th and 75th percentiles).
The primary endpoints of the proportion of patients exhibiting local control at 18 to 36 months (1) and the proportion of patients achieving biochemical progression-free survival at 5 years (2), will be analysed using proportions, and in the case of the latter outcome, a single-group Kaplan-Meier survival curve.
In regard to secondary endpoints, changes in variables such as FACT-G7 over time will be assessed using methods appropriate for analysis of longitudinal data, such as mixed models / hierarchical linear modelling or generalised estimating equations (GEE) models appropriate to the scale of data being measured and the sample size. Appropriate graphs of changes over time and simple pairwise comparison between baseline and 6 weeks, then every 6 months up to 5 years or withdrawal will also be presented, with maximum change being expected between baseline and 6 weeks following treatment. If missing or questionable data are identified, the study team will clarify and seek restoration of missing observations. If unable to be identified from source the missing observations will be reported for all endpoints.
95% confidence intervals will be presented throughout, and any tests of statistical significance will employ an alpha of 0.05, two-tailed. All analyses will be conducted using standard professional statistical software, such as Stata (Stata Corporation, College Station, Texas).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29816 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 46169 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 322390 0
Charities/Societies/Foundations
Name [1] 322390 0
Philanthropy
Country [1] 322390 0
Australia
Primary sponsor type
Government body
Name
Bayside Health (Alfred)
Address
Country
Australia
Secondary sponsor category [1] 325312 0
None
Name [1] 325312 0
Address [1] 325312 0
Country [1] 325312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320891 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 320891 0
Ethics committee country [1] 320891 0
Australia
Date submitted for ethics approval [1] 320891 0
19/02/2025
Approval date [1] 320891 0
03/04/2025
Ethics approval number [1] 320891 0
103/25

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151978 0
Prof Jeremy Grummet
Address 151978 0
Alfred Health, 55 Commercial Road, Melbourne VIC 3004
Country 151978 0
Australia
Phone 151978 0
+61 3 9903 0941
Fax 151978 0
Email 151978 0
[email protected]
Contact person for public queries
Name 151979 0
Ashley Baring
Address 151979 0
Alfred Centre, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 151979 0
Australia
Phone 151979 0
+61 3 9903 0941
Fax 151979 0
Email 151979 0
[email protected]
Contact person for scientific queries
Name 151980 0
Professor Jeremy Grummet
Address 151980 0
Alfred Health, 55 Commercial Road, Melbourne VIC 3004
Country 151980 0
Australia
Phone 151980 0
+61 3 9903 0941
Fax 151980 0
Email 151980 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.