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Trial registered on ANZCTR


Registration number
ACTRN12621001674820
Ethics application status
Approved
Date submitted
11/10/2021
Date registered
7/12/2021
Date last updated
7/12/2021
Date data sharing statement initially provided
7/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
18F-DCPYL-Positron Emission Tomography (PET) for diagnosis of primary prostate cancer in men with positive multiparametric magnetic resonance imaging (mpMRI) and negative biopsy
Scientific title
18F-DCPYL-PET for diagnosis of primary prostate cancer in men with positive mpMRI and negative biopsy
Secondary ID [1] 305727 0
Nil
Universal Trial Number (UTN)
Trial acronym
PEPCAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
primary prostate cancer in men with positive mpMRI and negative biopsy 323905 0
Condition category
Condition code
Cancer 321421 321421 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Substance/Device intervention: 18F - DCPyL - Positron Emission Tomography/Computed Tomography (PET/CT)

PET/CT Scan: Uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions. By identifying body changes at the cellular level, PET may detect the early onset of disease before it is evident on other imaging tests. A certified PET radiologist will perform the imaging. The PET/CT scan will be performed once only and last approximately 120 minutes.

18FDCPyL is the PET Radiotracer, injected into the arm or hand vein intravenously. The small amount of radioactive substance will allow the PET to detect radioactivity. Patients will be administered a single, intravenous bolus dose of 18F-DCFPyL PSMA. 250MBq 18F-DCFPyL (acceptable: 200-350MBq depending on patient weight and activity provided on day of scan) (calculated according to body weight and available activity). The administered activity of 18F-DCFPyL PSMA is approximately 3MBq per kilogram bodyweight up to 350 maximum dose.

Participants will be enrolled via strict inclusion/exclusion criteria and will be thoroughly examined prior to imaging to ensure there is no additional risks to participants. During imaging, a radiologist, a nuclear medicine technician and/or research nurse will be present from PSMA does through to end of imaging session to ensure participants are safely monitored.
Intervention code [1] 321917 0
Diagnosis / Prognosis
Comparator / control treatment
Patients with equivocal or positive 18F-DCPyL –PET scans will have their pre-existing mpMRI prostate reviewed to examine for a lesions and whether or not their location corresponds to the 18F-DCPyL –PET scan.
Control group
Active

Outcomes
Primary outcome [1] 329195 0
To assess the diagnostic accuracy of 18F-DCPyL PET/CT to detect prostate cancer in the management of men with a high clinical index of suspicion for presence of prostate cancer, with prior negative prostate biopsy.

The presence of prostate cancer is a binary outcome but any prostate cancer found will be graded according to the International Society of Urological Pathology (ISUP) grading system. A significant prostate cancer is defined as one with ISUP grading system greater than or equal to 2 out of 5. For the purposes of analysis, we define a positive MRI lesion as one greater than or equal to 5mm in size and greater than or equal to PI-RADS 4.
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be calculated for 18F-DCPyL-PET outcome compared to mpMRI.
Timepoint [1] 329195 0
1-2 weeks post-18F-DCPYL-PET scan
Primary outcome [2] 329665 0
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be calculated for Prostate biopsy outcome (significant cancer yes/no) compared to 18F-DCPyL-PET/CT
Timepoint [2] 329665 0
1-2 weeks post-18F-DCPYL-PET scan
Primary outcome [3] 329666 0
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be calculated for Prostate biopsy outcome (significant cancer yes/no) compared to 18F-DCPyL-PET/CT. Analysis will be performed at the per-patient level, and if multiple lesions are present at a per-lesion level.
Timepoint [3] 329666 0
1-2 weeks post-18F-DCPYL-PET scan
Secondary outcome [1] 401747 0
To report the safety of 18F-DCPyL-PET/CT in this group of patients.

Safety assessed as adverse events documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0) and as per NHMRC guidelines.
Timepoint [1] 401747 0
Safety will be monitored continuously from intervention commencement to 48 hours post-intervention completion
Secondary outcome [2] 403351 0
To evaluate the cost of 18F-DCPyL PET/CT imaging strategy.
By performing the PET/CT and confirming known cancer, a negative result will allow us to defer the patient from the current standard of care follow-up tests (ie. periodic MRIs & biopsies).
Costs will be measured by evaluating patients repeated prostate biopsies following imaging in this group of men as compared to standard of care imaging strategies. This will be done by calculating difference between resource use and costs from hospital medical records, patient out-of-pocket costs and/or economic benefit such as quality adjusted life years (QALYS).
Timepoint [2] 403351 0
The cost of 18F-DCPyL PET/CT imaging strategy will be evaluated at the conclusion of the trial.
Secondary outcome [3] 403352 0
To report the feasibility of 18F-DCPyL-PET/CT in this group of patients.

Feasibility will be measured by evaluation patient response/satisfaction following 18F-DCPyL-PET/CT scans. Patient satisfaction will be assessed by using study-specific survey administered by their treating urologist.
We will also measure time taken from scan to analysis and then subsequent reporting back to the referring Urologist as determined from patient medical records
Timepoint [3] 403352 0
Feasibility will be monitored continuously from intervention commencement to 1-2 weeks post-intervention completion

Eligibility
Key inclusion criteria
High clinical suspicion for prostate cancer (within 12mo) based on the following criteria:
• positive mpMRI suggesting presence of prostate cancer, but who have had a negative prostate biopsy.
• Prostate-Specific Antigen (PSA) >10 or
• PSA density > 0.15 or
• Palpable abnormality on Digital Rectal Exam (DRE) or
• MRI lesion PIRADS greater than or equal to 4 and size >5mm
AND
men with greater than or equal to 1 negative prostate biopsy, undertaken via any of the following techniques:
- cognitive fusion transrectal
- cognitive fusion transperineal
- software fusion transperineal
• Age 18 years and above
• Patient has provided written informed consent for participation in this trial
• In the opinion of investigator, willing and able to comply with required study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have developed interval contra-indication to have mpMRI prostate:
• MRI incompatible implants or metal fragments
• claustrophobia
• unable to have intravenous gadolinium
• unable to fit in the MRI due to BMI

Significant inter-current morbidity that, in the judgment of the investigator, would limit 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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary analysis will be diagnostic accuracy, assessed by the AUC. For a binary valued diagnostic instrument, the AUC is equal to the mean of the sensitivity and specificity. The power of the trial is dependent on the sensitivity and specificity of both diagnostic tools, as well as the ratio of cases to controls. The primary outcome is to assess the ability of 18F-DCPyL-PET to detect the presence of prostate cancer suggested by mpMRI. The presence of prostate cancer is a binary outcome but any prostate cancer found will be graded according to the International Society of Urological Pathology (ISUP) grading system. A significant prostate cancer is defined as one with ISUP grading system greater than or equal to 2 out of 5. For the purposes of analysis, we define a positive MRI lesion as one greater than or equal to 5mm in size and greater than or equal to PI-RADS 4.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/06/2018
Date of last participant enrolment
Anticipated
Actual
11/12/2020
Date of last data collection
Anticipated
Actual
31/03/2021
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20713 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 20714 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 35516 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309882 0
Hospital
Name [1] 309882 0
St Vincent’s Hospital Melbourne
Country [1] 309882 0
Australia
Funding source category [2] 309884 0
Other
Name [2] 309884 0
Reece Group
Country [2] 309884 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 311323 0
None
Name [1] 311323 0
Address [1] 311323 0
Country [1] 311323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309608 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 309608 0
Ethics committee country [1] 309608 0
Australia
Date submitted for ethics approval [1] 309608 0
13/11/2017
Approval date [1] 309608 0
13/02/2018
Ethics approval number [1] 309608 0
HREC/17/SVHM/269

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

Contacts
Principal investigator
Name 114754 0
Mr Lih-Ming Wong
Address 114754 0
St Vincent's Hospital Melbourne
Suite 2/141 Grey St, East Melbourne VIC 3002
Country 114754 0
Australia
Phone 114754 0
+61 3 9419 5290
Fax 114754 0
Email 114754 0
lih-ming.wong@svha.org.au
Contact person for public queries
Name 114755 0
Tam Nguyen
Address 114755 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, VIC 3065
Country 114755 0
Australia
Phone 114755 0
+61 3 9231 3930
Fax 114755 0
Email 114755 0
Research.Ethics@svhm.org.au
Contact person for scientific queries
Name 114756 0
Lih-Ming Wong
Address 114756 0
St Vincent's Hospital Melbourne
Suite 2/141 Grey St, East Melbourne VIC 3002
Country 114756 0
Australia
Phone 114756 0
+61 3 9419 5290
Fax 114756 0
Email 114756 0
lih-ming.wong@svha.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 overall de-identified study data for this trial will be available


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.