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Trial registered on ANZCTR


Registration number
ACTRN12623001082695
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
12/10/2023
Date last updated
12/10/2023
Date data sharing statement initially provided
12/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic Accuracy of 68Ga-PSMA PET/CT to identify residual Prostate Cancer Following Focal therapy with Irreversible Electroporation (NanoKnife).
Scientific title
Diagnostic Accuracy of 68Ga-PSMA PET/CT to identify residual Prostate Cancer Following Focal therapy with Irreversible Electroporation for localized Prostate Cancer: A Prospective Study
Secondary ID [1] 310627 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 331506 0
Condition category
Condition code
Cancer 328240 328240 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PET tracer, 68Ga-PSMA, is a PSMA ligand radiolabelled with Gallium-68 to enable its use for PET imaging which is intravenously injected in patients prior to the scan (289.9 to 414 MBq ). This whole process can take up to an hour to conduct. This procedure is conducted by PET Scientists/Technologists as per standard procedure at site. The patients are only discharged from clinic upon assessment of no adverse events reported.

68Ga PSMA PET/CT prior to Irreversible Electroporation will be conducted as per standard of care as a Medicare Benefits Schedule (MBS) item for the initial staging of intermediate to high-risk patients with prostate cancer since 1st Jul 2022
An additional scan will be conducted at 9-12 months post Irreversible Electroporation.
Intervention code [1] 327028 0
Diagnosis / Prognosis
Comparator / control treatment
The multiparametric (mpMRI) is used as a standard of care procedure and will involve a 0.1 mmol/kg of a gadolinium-based contrast followed by a flush of 20 ml of 0.9% saline. The procedure can take approx 1 hr. The mpMRI will be collected prior to NanoKnife procedure (baseline) and 6-12 months post NanoKnife as per standard of care. Both mpMRI and PSMA PET scans will occur prior to the biopsy post NanoKnife.

The intravenous cannulation (to allow contrast administration) can be associated with mild discomfort. A very small risk (~1 in 250) of a mild to moderate, self-limiting, non-life-threatening contrast induced reaction, which can include rash or itching at the injection site, nausea, vomiting, headache, dizziness, paraesthesia can occur. An extremely small risk of a life-threatening anaphylactoid reaction (~1 in 100,000 to 500,000) can occur.
Extremely rarely, injury and death can occur in MRI units from unsecured metal objects being drawn at high speeds into the magnet or from internal body metal fragments of which the subject was unaware or had not informed MRI staff. The referring urologist and MRI staff prior to the mpMRI will perform a screening questionnaire to reduce this risk. Other remote but potential risks involve tissue burns and temporary hearing loss from the loud noises inside the magnet. Headphone protection will be used that also allows continuous communication between the subject and staff during the study.
The FDA has indicated that for clinical diagnosis an “insignificant” risk is associated with human MRI exposure at the intensities used in this project and is considered a safe procedure used in everyday clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 336110 0
Establish the diagnostic accuracy of PSMA PET/CT in detecting residual/recurrent clinically significant Prostate cancer at 12 months post focal IRE, defined as gleason score grade group 2-5 (with >1mm of pattern 4 present).
Timepoint [1] 336110 0
12 months after Irreversible Electroporation
Secondary outcome [1] 426864 0
Assess the accuracy of PSMA PET/CT using negative predictive value (NPV), positive predictive value (PPV), sensitivity and specificity as a composite secondary outcome to detect grade group 3-5
Timepoint [1] 426864 0
At Baseline prior to Irreversible Electroporation and 12 months after Irreversible Electroporation
Secondary outcome [2] 426865 0
Assess the number of patients with residual/recurrent PCa that required further intervention/treatment.
Timepoint [2] 426865 0
At Baseline prior to Irreversible Electroporation and 12 months after Irreversible Electroporation
Secondary outcome [3] 426866 0
Assess the incremental diagnostic utility of PSMA PET/CT in combination with mpMRI (NPV/PPV/sensitivity/specificity as a composite secondary outcome) in the detection of disease progression post IRE, i.e. to evaluate whether the combination of mpMRI and PSMA PET or either test alone could enable 12-month biopsy to be omitted.
Timepoint [3] 426866 0
At Baseline prior to Irreversible Electroporation and 12 months after Irreversible Electroporation
Secondary outcome [4] 426867 0
Assess the accuracy of targeted biopsies versus template biopsies ability to detect clinically significant PCa identified on mpMRI and PSMA PET/CT.
Timepoint [4] 426867 0
At Baseline prior to Irreversible Electroporation and 12 months after Irreversible Electroporation
Secondary outcome [5] 426868 0
Assess the anatomic concordance using the quadrant based analysis to compare the imaging (mpMRI and PSMA PET/CT) versus histopathology (biopsy and radical prostatectomy) at 12 months. Comparative accuracy of PSMA PET/CT and/or mpMRI to predict late recurrence/progression at 3-5 years.
Timepoint [5] 426868 0
At Baseline prior to Irreversible Electroporation and 12 months after Irreversible Electroporation
Secondary outcome [6] 426870 0
Analysis of imaging inter-reporter variability
Timepoint [6] 426870 0
12 month post irreversible electroporation
Secondary outcome [7] 427280 0
Assess the accuracy of PSMA PET/CT using negative predictive value (NPV), positive predictive value (PPV), sensitivity and specificity as a composite secondary outcome to detect grade group 4-5
Timepoint [7] 427280 0
At Baseline prior to Irreversible Electroporation and 12 months after Irreversible Electroporation

Eligibility
Key inclusion criteria
• Male greater or equal to 18 years and over
• Undergoing primary focal IRE (Nanoknife®) procedure
• Available mpMRI +/- PSMA PET/CT prior to focal IRE (Nanoknife®) procedure
• Planned for follow up transperineal biopsy as part of standard clinical follow up at 12-18 months post IRE (Nanoknife®)
• Willingness to give signed patient information and consent form (PISCF)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-PSMA avid primary lesion on PSMA prior to IRE
• Unwilling to undergo PSMA PET/CT at 9-12 months
• Unwilling to undergo follow up transperineal biopsy
• Unwilling or unable to consent to participation in the study
• Contraindication to repeat PSMA PET/CT at 9-12 months follow-up

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25548 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 41369 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 314844 0
Other Collaborative groups
Name [1] 314844 0
St Vincent's Prostate Cancer Research Centre
Country [1] 314844 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Private Hospital
Address
406 Victoria St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 316835 0
None
Name [1] 316835 0
Address [1] 316835 0
Country [1] 316835 0
Other collaborator category [1] 282815 0
Hospital
Name [1] 282815 0
St Vincent's Public Hospital
Address [1] 282815 0
370 Victoria Street Darlinghurst NSW 2010
Country [1] 282815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313845 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 313845 0
St. Vincent's Health Network Translational Research Centre | 97-105 Boundary Street Darlinghurst NSW 2010
Ethics committee country [1] 313845 0
Australia
Date submitted for ethics approval [1] 313845 0
23/06/2023
Approval date [1] 313845 0
10/08/2023
Ethics approval number [1] 313845 0
2023/ETH01386

Summary
Brief summary
This is a prospective single site study evaluating the additive value of a diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference mpMRI scan in men who have undergone Focal therapy for prostate cancer with Irreversible Electroporation (IRE) procedure.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with prostate cancer and you are scheduled to undergo a primary focal IRE (Nanoknife®) procedure as part of your cancer treatment. You should also have undergone both a PSMA PET/CT scan and an mpMRI scan prior to any surgical treatment as these images will be used for comparisons.

Study details
All participants who choose to enrol in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 12 months of undergoing the IRE procedure to treat their cancer. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and a biopsy (tissue sample) of any remaining tissue.

It is hoped this research will determine whether adding a PSMA PET/CT scan to the current standard of care mpMRI scan is able to better detect residual/recurrent clinically significant prostate cancer. If the PSMA PET/CT scan is found to be a helpful addition to the current mpMRI scan, or is found to be more accurate in detecting prostate cancer than the mpMRI scan, a larger trial involving a greater number of patients with prostate cancer may be undertaken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129530 0
Prof Phillip Stricker
Address 129530 0
St Vincent's Clinic, Level 10, 438 Victoria St, Darlinghurst NSW 2010
Country 129530 0
Australia
Phone 129530 0
+61 2 8382 6971
Fax 129530 0
Email 129530 0
phillip@stricker.com.au
Contact person for public queries
Name 129531 0
Mrs Shikha Agrawal
Address 129531 0
The Kinghorn Cancer Centre, 370 Victoria St, Darlinghurst NSW 2010
Country 129531 0
Australia
Phone 129531 0
+61 402901143
Fax 129531 0
Email 129531 0
shikha.agrawal@svha.org.au
Contact person for scientific queries
Name 129532 0
Prof Phillip Stricker
Address 129532 0
St Vincent's Clinic, Level 10, 438 Victoria St, Darlinghurst NSW 2010
Country 129532 0
Australia
Phone 129532 0
+61 2 8382 6971
Fax 129532 0
Email 129532 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.