Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001648819
Ethics application status
Approved
Date submitted
7/10/2021
Date registered
1/12/2021
Date last updated
1/12/2021
Date data sharing statement initially provided
1/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
CONFIRM: The Diagnostic Utility of Prostate Specific Membrane Antigen Positron Emission Tomography/Computed tomography (PSMA PET/CT) in Men with Newly Diagnosed Low-Grade Prostate Cancer with High-Risk Features, on Active Surveillance (regular testing for any changes in the cancer that could lead to harm), Awaiting Confirmatory Biopsy
Scientific title
The Diagnostic Utility of PSMA PET/CT in Men with Newly Diagnosed Low-Grade Prostate Cancer with High-Risk Features, on Active Surveillance, Awaiting Confirmatory Biopsy
Secondary ID [1] 305287 0
Nil
Universal Trial Number (UTN)
Trial acronym
CONFIRM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 323590 0
Condition category
Condition code
Cancer 321135 321135 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to standard repeat mpMRI of the prostate, men on active surveillance for prostate cancer who are approaching their confirmatory prostate biopsy will also receive a Prostate Specific Membrane Antigen Positron Emission Tomography/Computed tomography (PSMA PET-CT) scan. Should the PSMA PET-CT scan demonstrate a lesion that was otherwise not detected by the mpMRI, an additional PSMA-targeted biopsy will be taken at the time of the confirmatory biopsy.

To prepare for the PSMA PET/CT scan, the participant needs to receive an injection of a radioactive substance (18F-DCPyL) through their arm/hand vein. They will need to wait up to 1 hour for the radioactive substance to travel through their bloodstream before the actual scan takes place. The scan takes 20-30 minutes. The entire PSMA PET/CT procedure takes around 2-2.5 hours and can be completed in one visit and it can begin immediately following the MRI scan.

The PSMA PET/CT and the repeat standard mpMRI both need to be completed between 3-6 months after the participant has been diagnosed with prostate cancer.

All confirmatory biopsies (including the PSMA-targeted biopsy) will be carried out by the same urologist who took the initial diagnostic biopsy. All confirmatory biopsies will be taken within a single visit. The systematic and the mpMRI targeted biopsy are standard of care.

The PSMA-targeted biopsy is only applicable if the PSMA PET/CT scans detect a new lesion. It would take no more than an additional 10 minutes to standard of care. The PSMA-targeted biopsy will occur no more than 3 months after the PSMA PET/CT scan.

To monitor adherence, the study team will book all participants for their PSMA PET-CT at Epworth Freemasons. The study team will be in ongoing communication with the participants and their local urologists.
After all of the scans (mpMRI and PSMA PET-CT) and confirmatory biopsies (systematic +/- MRI-targeted +/- PSMA-targeted) have been completed and reported, each case will be presented to a dedicated Epworth Uro-oncology multidisciplinary team. Initially only results from standard/current treatment will be shared. The panel of experts will then provide their recommendation as to whether the patient should remain on active surveillance for their prostate cancer, or receive active treatment (surgery or radiotherapy).
Next, the results from the PSMA PET-CT scan and targeted biopsies will be shared with the panel. They then have the option to stick with their initial recommendation, or change it.

The standard of care for prostate cancer patients on active surveillance is the repeat mpMRI and confirmatory biopsy (without the PSMA PET/CT scan and the PSMA-targeted biopsy).

The panel's recommendation will be shared with the participant and their treating doctor
Intervention code [1] 321692 0
Diagnosis / Prognosis
Comparator / control treatment
Patients will act as their own controls.
The repeat mpMRI, the systematic biopsy and the mpMRI-targeted biopsy are all considered standard of care for prostate cancer patients on active surveillance. However, they will be conducted according to the CONFIRM protocol. To reduce variables, all biopsies will be sent to Tissupath for reporting and all repeat mpMRIs will be done at Epworth Medical Imaging, Freemasons.

The confirmatory biopsy will occur as soon as possible following the repeat MRI. The repeat MRI can occur anytime between 3-6 months after the initial diagnostic biopsy
Control group
Active

Outcomes
Primary outcome [1] 328922 0
The proportion of treatment-warranting prostate cancer that can be detected by PSMA PET/CT and PSMA-targeted biopsy relative to a 3-6 month repeat mpMRI and mpMRI-targeted biopsy
Timepoint [1] 328922 0
At the time of confirmatory biopsy of the prostate.
Primary outcome [2] 329536 0
The negative predictive value of PSMA PET/CT in on men on active surveillance with low grade prostate cancer with high risk features
Timepoint [2] 329536 0
At the time of the confirmatory biopsy
Secondary outcome [1] 402408 0
The positive predictive value (PPV), sensitivity and specificity of PSMA PET/CT scan for active surveillance prostate cancer patients with high risk features
Timepoint [1] 402408 0
At the time of the confirmatory biopsy of the prostate

Eligibility
Key inclusion criteria
Any man, 18-years and over who has undergone prostate biopsy with a new diagnosis of prostate cancer, being managed through active surveillance, with one or more of the following 'high-risk features':

- GG2 cancers where the amount of pattern 4 is 10% or less
- GG1 cancers which are considered to be high volume
- GG1 cancers that have PIRADS 4 or 5 lesion on the MRI
- Low volume GG1 cancer but has a high PSA
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- A history of other active malignancy within the last 5 years, with exception of non-melanoma skin cancer
- A known history of prostate cancer
- A diagnostic prostate biopsy of more than 6 months prior
- Contra-indication to 3T mpMRI or PSMA PET/CT
- Significant intercurrent morbidity limiting compliance with study protocols

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
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
Descriptive statistics will be reported using frequencies and percentages for 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, with medians and interquartile ranges (difference between 25th and 75th percentiles) reported for potentially skewed data, identified using standard graphical procedures.

The primary endpoint of proportion who were Upgrade Negative following presentation of standard results (mpMRI scan, systematic confirmatory biopsy, and mpMRI-targeted biopsy,) but Upgrade Positive following presentation of the PSMA-related investigations (PSMA PET/CT, PSMA-targeted biopsy), less those who were Upgrade Positive with standard investigations, but Upgrade Negative with PSMA-related investigations. This will be analysed using McNemar’s test for change, or conditional logistic regression if potential confounders such as age and cancer severity at original diagnosis are included in the model.

The primary endpoint of negative predictive value will be generated along with Clopper-Pearson 95% confidence intervals as will secondary endpoints positive predictive value, sensitivity and specificity.

A ‘per protocol’ sensitivity analysis will be restricted to participants who did not have a major protocol deviation. Major protocol deviations will be identified prior to database lock.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2021
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
223
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20668 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [2] 20669 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [3] 20670 0
Epworth Richmond - Richmond
Recruitment hospital [4] 20671 0
Epworth Hospital Geelong - Waurn Ponds
Recruitment postcode(s) [1] 35463 0
3128 - Box Hill
Recruitment postcode(s) [2] 35464 0
3002 - East Melbourne
Recruitment postcode(s) [3] 35465 0
3121 - Richmond
Recruitment postcode(s) [4] 35466 0
3216 - Waurn Ponds

Funding & Sponsors
Funding source category [1] 309659 0
Charities/Societies/Foundations
Name [1] 309659 0
EJ Whitten Foundation Prostate Cancer Research Centre
Country [1] 309659 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
EJ Whitten Foundation Prostate Cancer Research Centre
Address
124 Grey St, East Melbourne, Victoria 3002
Country
Australia
Secondary sponsor category [1] 311246 0
None
Name [1] 311246 0
Address [1] 311246 0
Country [1] 311246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309426 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 309426 0
Ethics committee country [1] 309426 0
Australia
Date submitted for ethics approval [1] 309426 0
Approval date [1] 309426 0
09/08/2021
Ethics approval number [1] 309426 0
HREC 114/21

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

Contacts
Principal investigator
Name 114122 0
A/Prof Nathan Lawrentschuk
Address 114122 0
EJ Whitten Foundation Prostate Cancer Research Centre, 124 Grey St, East Melbourne, Victoria 3002
Country 114122 0
Australia
Phone 114122 0
+61488088240
Fax 114122 0
Email 114122 0
[email protected]
Contact person for public queries
Name 114123 0
Dominic Bagguley
Address 114123 0
EJ Whitten Foundation Prostate Cancer Research Centre, 124 Grey St, East Melbourne, Victoria 3002
Country 114123 0
Australia
Phone 114123 0
+61431794780
Fax 114123 0
Email 114123 0
[email protected]
Contact person for scientific queries
Name 114124 0
Dominic Bagguley
Address 114124 0
EJ Whitten Foundation Prostate Cancer Research Centre, 124 Grey St, East Melbourne, Victoria 3002
Country 114124 0
Australia
Phone 114124 0
+61431794780
Fax 114124 0
Email 114124 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13462Study protocol  [email protected]
13463Informed consent form  [email protected]
13464Ethical approval  [email protected]



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.