ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

DEFER trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

prostate cancer

Condition category

Condition code

Surgery

Surgical techniques

Cancer

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]

Treatment: Surgery

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

In field prostate cancer recurrence on transperineal biopsy

Timepoint [1]

12 months after surgery

Secondary outcome [1]

Utility of PSMA PET scans in patient selection for focal irreversible electroporation

Timepoint [1]

During diagnostic workup and characterisation of prostate cancer. This can be anytime prior to surgery.

Secondary outcome [2]

Patient reported outcomes using EPIC 26 Quality of life questionnaire - urinary function, sexual function, bowel habits, hormonal function

Timepoint [2]

12 months after surgery

Secondary outcome [3]

Utility of PSMA PET scans in detection of recurrence following focal irreversible electroporation

Timepoint [3]

12 months after surgery

Secondary outcome [4]

Utility of MRI scans in detection of recurrence following focal irreversible electroporation

Timepoint [4]

12 months after surgery

Secondary outcome [5]

Utility of serum PSA in detection of recurrence following focal irreversible electroporation

Timepoint [5]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Freemasons (Clarendon Street) - East Melbourne

Recruitment postcode(s) [1]

3002 - East Melbourne

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

EJ Whitten Prostate Cancer Research Centre at Epworth

Address [1]

124 Grey St, East Melbourne, VIC, 3002

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Nathan Lawrentschuk

Address

89 Bridge Rd, Richmond VIC 3121

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent’s Human Research Ethics Committee

Ethics committee address [1]

41 Victoria Parade Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/05/2021

Ethics approval number [1]

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

A/Prof Nathan Lawrentschuk

Address

Epworth HealthCare - 89 Bridge Rd, Richmond VIC 3121

Country

Australia

Phone

+61 03 9329 1197

Fax

urooncologist@gmail.com

Contact person for public queries

Name

Thilikavathi Chengodu

Address

Epworth HealthCare - 89 Bridge Rd, Richmond VIC 3121

Country

Australia

Phone

+61 03 9483 6033

Fax

Thili.Chengodu@epworth.org.au

Contact person for scientific queries

Name

Thilikavathi Chengodu

Address

Epworth HealthCare - 89 Bridge Rd, Richmond VIC 3121

Country

Australia

Phone

+61 03 9483 6033

Fax

Thili.Chengodu@epworth.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically