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Trial registered on ANZCTR


Registration number
ACTRN12621001652864
Ethics application status
Approved
Date submitted
14/10/2021
Date registered
1/12/2021
Date last updated
4/11/2022
Date data sharing statement initially provided
1/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Deferral of active treatment using focal irreversible electroporation for men with localised prostate cancer
Scientific title
The efficacy of treatment with focal irreversible electroporation for men with localised prostate cancer
Secondary ID [1] 305249 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DEFER trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 323949 0
Condition category
Condition code
Surgery 321467 321467 0 0
Surgical techniques
Cancer 321688 321688 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Qualified Urologists will perform focal irreversible electroporation (IRE) for men with localised prostate cancer. This will be done in a surgical theatre with the patient under general anaesthesia. This procedure usually take around 30-60mins.

IRE will be performed at an Epworth HealthCare affiliated hospital. This will be a day procedure. Participants will be discharged with Panadol and voltaren for pain and flomaxtra for any urinary issues. They will also had a urinary catheter on discharge. This will be removed via trial of void by a urology nurse 2-5 days post operatively.

Follow up will consist of a 3, 6 and 12 months review. This will be done in clinic with the treating Urologist. At 3 months, participants will be assessed with a serum PSA, and completed EPIC-26 Quality of Life questionnaire. At 6 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire and prostate MRI. At 12 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire, PSMA PET and prostate biopsy. These follow up protocols coincide with the published Delphi consensus for focal therapy.
Intervention code [1] 321953 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329244 0
In field prostate cancer recurrence on transperineal biopsy
Timepoint [1] 329244 0
12 months after surgery
Secondary outcome [1] 401880 0
Utility of PSMA PET scans in patient selection for focal irreversible electroporation
Timepoint [1] 401880 0
During diagnostic workup and characterisation of prostate cancer. This can be anytime prior to surgery.
Secondary outcome [2] 401881 0
Patient reported outcomes using EPIC 26 Quality of life questionnaire - urinary function, sexual function, bowel habits, hormonal function
Timepoint [2] 401881 0
12 months after surgery
Secondary outcome [3] 402672 0
Utility of PSMA PET scans in detection of recurrence following focal irreversible electroporation
Timepoint [3] 402672 0
12 months after surgery
Secondary outcome [4] 402673 0
Utility of MRI scans in detection of recurrence following focal irreversible electroporation
Timepoint [4] 402673 0
12 months after surgery
Secondary outcome [5] 403549 0
Utility of serum PSA in detection of recurrence following focal irreversible electroporation
Timepoint [5] 403549 0
12 months after surgery

Eligibility
Key inclusion criteria
1) Primary prostate cancer (PCa) diagnosis
a. Gleason score less than or equal to 7 (grade group 3 or less)
b. Radiological stage T1-T3
c. No previous treatment for PCa
2) Radio-recurrent prostate cancer
a. Radio-recurrent prostate cancer greater or equal to 2 years post LDR/PDR/HDR brachytherapy or EBRT
3) Both groups
a. Imaging negative for metastatic disease
b. Radiological stage T1-T3
c. Lesion visible on prostate MRI
d. Unilateral or single midline anterior/posterior index tumour, allowing single targeted ablative therapy
e. Lesion confirmed with targeted prostate biopsy
f. Life expectancy over 10 years
g. No previous androgen suppression/hormone treatment for PCa
h. Can give written consent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Biopsy proven lymph node involvement
• Metastatic disease
• Bowel disease (e.g. IBD)
• Previous transurethral resection of the prostate (TURP)
• Inability to undergo mpMRI
• Incompatible metallic implants
• Claustrophobia
• Men unable to tolerate transrectal ultrasound
• Men who have undergone previous focal therapy to the prostate
o HIFU, IRE, cryosurgery, thermal, microwave, laser therapy
• Men who have received androgen suppression/hormone treatment within the last 6 months
• Metallic implants or stents in urethra
• Histological evidence of any cancer in more than one area of the prostate
• Requires simultaneous urological procedure at time of salvage IRE (e.g. mini-TUR)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The rate of prostate cancer recurrence and adverse events reporting will be reported using absolute numbers. Comparison of functional outcomes (before and after IRE) and imaging modalities will be performed using paired sample t-test or Wilcoxon signed-ranks tests depending on the distribution.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20728 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment postcode(s) [1] 35536 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 309621 0
Charities/Societies/Foundations
Name [1] 309621 0
EJ Whitten Prostate Cancer Research Centre at Epworth
Country [1] 309621 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nathan Lawrentschuk
Address
89 Bridge Rd, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 310953 0
None
Name [1] 310953 0
none
Address [1] 310953 0
none
Country [1] 310953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309395 0
St Vincent’s Human Research Ethics Committee
Ethics committee address [1] 309395 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 309395 0
Australia
Date submitted for ethics approval [1] 309395 0
Approval date [1] 309395 0
17/05/2021
Ethics approval number [1] 309395 0

Summary
Brief summary
Prostate cancer continues to be one of the most commonly diagnosed cancer in men and a leading cause of cancer related death worldwide. When prostate cancer is in its early stages, meaning that it has not spread outside the prostate gland, surgical excision of the prostate and radiation to the pelvis have been shown to be effective treatments. However, these treatments frequently leave men with side effects. The main two being erectile dysfunction and urinary incontinence. Over the last decade, new treatment strategies have been aimed at delaying or mitigating the need for prostate excision or radiation therapy to save men from these side effects.

Irreversible electroporation (IRE) is a new form of technology which uses electrical pulses to kill cancer cells within the prostate. These electrical pulses are applied through metal probes placed strategically around the cancer in the prostate. The heat generated is kept below “thermal” levels to ensure important structures that surround the prostate (nerves and blood vessels) are not damaged by the treatment. For the moment, studies on IRE have been limited by numbers and short term follow up data.

This study will follow and analyse men undergoing IRE. It will include men who have newly diagnosed localised prostate cancer and also men who have localised recurrent prostate cancer after radiotherapy. We aim to assess cancer outcomes through a series of imaging (MRI and PSMA PET/CT), blood tests and biopsies (TP biopsy). Additionally, we aim to analyse functional outcomes through questionnaires. Our study will add the growing evidence of men undergoing IRE around the world.

Who is it for?
You may be eligible to participate if you are aged 18 years or older, and have been diagnosed with prostate cancer - either newly diagnosed localised prostate cancer, or localised recurrent prostate cancer after radiotherapy.

Study details:
All participants will undergo IRE surgery, conducted under general anaesthesia. The surgery will take around 30-60mins.

Follow up will consist of a 3, 6 and 12 months review. This will be done in clinic with the treating Urologist. At 3 months, participants will be assessed with a serum PSA, and completed EPIC-26 Quality of Life questionnaire. At 6 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire and prostate MRI. At 12 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire, PSMA PET and prostate biopsy.

It is hoped that this research will improve understanding of IRE treatment, and lead to better treatment for men with prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114006 0
A/Prof Nathan Lawrentschuk
Address 114006 0
Epworth HealthCare - 89 Bridge Rd, Richmond VIC 3121
Country 114006 0
Australia
Phone 114006 0
+61 03 9329 1197
Fax 114006 0
Email 114006 0
[email protected]
Contact person for public queries
Name 114007 0
Thilikavathi Chengodu
Address 114007 0
Epworth HealthCare - 89 Bridge Rd, Richmond VIC 3121
Country 114007 0
Australia
Phone 114007 0
+61 03 9483 6033
Fax 114007 0
Email 114007 0
[email protected]
Contact person for scientific queries
Name 114008 0
Thilikavathi Chengodu
Address 114008 0
Epworth HealthCare - 89 Bridge Rd, Richmond VIC 3121
Country 114008 0
Australia
Phone 114008 0
+61 03 9483 6033
Fax 114008 0
Email 114008 0
[email protected]

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.