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Trial registered on ANZCTR


Registration number
ACTRN12622000021774
Ethics application status
Approved
Date submitted
11/11/2021
Date registered
12/01/2022
Date last updated
20/01/2023
Date data sharing statement initially provided
12/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immunomodulatory effects following focal ablation of localized prostate cancer with irreversible electroporation (IRE)
Scientific title
Immunomodulatory effects following focal ablation of localized prostate cancer with irreversible electroporation
Secondary ID [1] 305710 0
Nil known
Universal Trial Number (UTN)
Trial acronym
IRE Immuno Trial
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Localised Prostate Cancer 324177 0
Condition category
Condition code
Cancer 321651 321651 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project is a single-centre proof of concept study conducted at St Vincent’s Private Hospital, Sydney (Patient recruitment and treatment centre). Patients that are planned for focal irreversible electroporation (IRE) also known as NanoKnife procedure will undergo venous blood collection prior to treatment (baseline) and 3, 14 and 30 days post IRE. The immunological response following IRE will be compared to patients that are treated by radical prostatectomy and have had blood collected at the same time points, to assess whether there is an ongoing systemic anti-tumour response.
Blood tests will only be used for the purpose of the study analysis and will not affect patient treatment
Intervention code [1] 322097 0
Diagnosis / Prognosis
Comparator / control treatment
The immunological response following IRE will be compared to patients that are treated by radical prostatectomy and have had blood collected at the same time points, to assess whether there is an ongoing systemic anti-tumour response. 20 IRE and 10 radical prostatectomy participants will be recruited.
The IRE and Radical prostatectomy procedures are conducted as per usual care by the urologist and not specific to the study
Control group
Active

Outcomes
Primary outcome [1] 329430 0
The degree of systemic anti-tumour immune response resulting from local IRE-mediated ablation of localized prostate cancer
Timepoint [1] 329430 0
To be assessed post IRE (3 days, 14 days and 30 days).
One EDTA tube with 4 ml blood per time point will be send to the clinical chemical lab for full blood count with leukocyte differentiation: neutrophilic granulocytes, lymphocytes, eosinophil granulocytes, basophilic granulocytes, monocytes.
Multiparametric flow cytometry will be performed to compare frequencies and activation status of both lymphocytic, myeloid and dendritic subsets in PBMC before and after treatment
Secondary outcome [1] 402568 0
To establish at what time point after IRE the systemic anti-tumour immune response is most active.
Timepoint [1] 402568 0
To be assessed post IRE (3 days, 14 days and 30 days).
One EDTA tube with 4 ml blood per time point will be send to the clinical chemical lab for full blood count with leukocyte differentiation: neutrophilic granulocytes, lymphocytes, eosinophil granulocytes, basophilic granulocytes, monocytes.
Multiparametric flow cytometry will be performed to compare frequencies and activation status of both lymphocytic, myeloid and dendritic subsets in PBMC before and after treatment
Secondary outcome [2] 404195 0
To compare the immune response to patient that are treated with radical prostatectomy.
Timepoint [2] 404195 0
To be assessed post IRE (3 days, 14 days and 30 days).
One EDTA tube with 4 ml blood per time point will be send to the clinical chemical lab for full blood count with leukocyte differentiation: neutrophilic granulocytes, lymphocytes, eosinophil granulocytes, basophilic granulocytes, monocytes.
Multiparametric flow cytometry will be performed to compare frequencies and activation status of both lymphocytic, myeloid and dendritic subsets in PBMC before and after treatment

Eligibility
Key inclusion criteria
Patients must meet the following inclusion criteria to be eligible to participate in the study
• Male, aged 18 years or over
• Confirmed adenocarcinoma of prostate with organ confined (less than or equal to cT2) disease and Gleason 3 + 4 = 7 or Gleason 4 + 3 = 7 prostate cancer.
• Currently scheduled for either IRE or radical prostatectomy
• No previously diagnosed prostate cancer
• No use of immunosuppressive drugs
• Ability to give written informed consent, participate in and comply with study
• Able to attend blood collection centre at appropriate time.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who meet any of the following exclusion criteria are not eligible to participate in the study
• Use of immunosuppressive drugs
• Previous diagnosis of prostate cancer
• Inability/ incapacity to provide own consent
• Inability/ incapacity for venous blood collection
• PSA >20ng/ml
• greater than or equal to cT3 on DRE

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a proof of concept pilot study, therefore we aim to include at least 20 IRE patients to correct for (natural) variation between patients and to account for potential missing/invalid samples. Since the (natural) variation following radical prostatectomy is expected to be lower we aim to include 10 post surgery patients. Statistically significant decreases in the percentage of T cells after treatment can be analysed with one-sided repeated measures ANOVA and a post-hoc Dunnett’s multiple comparisons test or a two-sided Student’s T test. T cell percentages post IRE will be compared with T cell percentages post prostatectomy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/02/2021
Date of last participant enrolment
Anticipated
29/04/2022
Actual
26/05/2022
Date of last data collection
Anticipated
29/05/2022
Actual
29/05/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21086 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 35843 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 310068 0
Commercial sector/Industry
Name [1] 310068 0
Angiodynamics, Inc.
Country [1] 310068 0
United States of America
Primary sponsor type
Hospital
Name
St. Vincent's Private Hospital
Address
406 Victoria St,
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 311123 0
None
Name [1] 311123 0
Address [1] 311123 0
Country [1] 311123 0
Other collaborator category [1] 282069 0
Other Collaborative groups
Name [1] 282069 0
The Garvan Institute of Medical Research
Address [1] 282069 0
The Garvan Institute of Medical Research
The Kinghorn Cancer Centre Building
Level 6, 370 Victoria street
Darlinghurst NSW 2010
Country [1] 282069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309760 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 309760 0
Ethics committee country [1] 309760 0
Australia
Date submitted for ethics approval [1] 309760 0
12/03/2020
Approval date [1] 309760 0
05/05/2020
Ethics approval number [1] 309760 0
2020/ETH00157

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

Contacts
Principal investigator
Name 115294 0
Prof Phillip Stricker
Address 115294 0
St Vincent's Clinic
Level 10/438 Victoria St,
Darlinghurst NSW 2010
Country 115294 0
Australia
Phone 115294 0
+61 2 83826971
Fax 115294 0
Email 115294 0
phillip@stricker.com.au
Contact person for public queries
Name 115295 0
Shikha Agrawal
Address 115295 0
The Garvan Institute of Medical Research
The Kinghorn Cancer Centre Building
Level 6, 370 Victoria street
Darlinghurst NSW 2010
Country 115295 0
Australia
Phone 115295 0
+61 2 9355 5735
Fax 115295 0
Email 115295 0
s.agrawal@garvan.org.au
Contact person for scientific queries
Name 115296 0
Bart Geboers
Address 115296 0
The Garvan Institute of Medical Research
The Kinghorn Cancer Centre Building
Level 6, 370 Victoria street
Darlinghurst NSW 2010
Country 115296 0
Australia
Phone 115296 0
+61 491169406
Fax 115296 0
Email 115296 0
b.geboers@garvan.org.au

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


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.