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Trial registered on ANZCTR


Registration number
ACTRN12620000261910
Ethics application status
Approved
Date submitted
18/02/2020
Date registered
27/02/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective single arm paired comparison of ability to locate and diagnose prostate cancer between multiparametric MRI, PSMA-PET/CT AND PSMA-PET MRI fusion
Scientific title
A prospective single arm paired comparison of ability to locate and diagnose prostate cancer between multiparametric MRI, PSMA-PET/CT AND PSMA-PET MRI fusion
Secondary ID [1] 299960 0
Nil
Universal Trial Number (UTN)
U1111-1244-7357
Trial acronym
PEDAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with features suspicious for prostate cancer 315405 0
Condition category
Condition code
Cancer 313703 313703 0 0
Prostate

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

Positron Emission Tomography (PET)Scan: Uses small amounts of radioactive materials calledradiotracers, 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.   
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.
Scanner: Patients will be imaged on a GE Discovery 710 PET/CT (General Electric Medical Systems, Milwaukee, WI) combining a 64 slice multidetector CT scanner with a dedicated, full ring PET scanner with lutetium-based crystals.
Injection of radiotracer and the imaging will be performed by a qualified radiologist/nuclear medicine PET-CT technician. Both mpMRI and the PET//CTs can will be performed once, post participant screening & consent and on the same day.
The PET/CT scan will take place 2 hours post injection of the 18F-DCFPyL PSMA for all patients. The duration of the PET/CT scan will take ~19 minutes for patients <90kg OR ~22 minutes for patients >90kg.
Intervention code [1] 316225 0
Early detection / Screening
Comparator / control treatment
multi-parametric magnetic resonance imaging (mpMRI) scan
Control group
Active

Outcomes
Primary outcome [1] 322796 0
Detection of prostate cancer by 18F-­DCPyL­-PET/CT.
Timepoint [1] 322796 0
7 days post commencement of treatment period.
Secondary outcome [1] 379826 0
Detection of prostate cancer by PSMA-PET MRI fusion.
Timepoint [1] 379826 0
7 days post commencement of treatment period

Eligibility
Key inclusion criteria
1. Men (greater to or equal than 18 years) with an elevated PSA who are suitable for an eligible MBS mpMRI prostate (MBS items 63541 and 63542 NK)
2. For MBS items 63541 and 63542 (NK) the patient must be suspected of having prostate cancer based on (*):
a) a digital rectal examination (DRE) which is suspicious for prostate cancer; or
b) in a person aged less than 70 years, at least two prostate specific antigen (PSA) tests performed within an interval of 1- 3 months are greater than 3.0 ng/ml, and the free/total PSA ratio is less than 25% or the repeat PSA exceeds 5.5 ng/ml; or
c) in a person aged less than 70 years, whose risk of developing prostate cancer based on family history is at least double the average risk, at least two PSA tests performed within an interval of 1-3 months are greater than 2.0 ng/ml, and the free/total PSA ratio is less than 25%; or
d) in a person aged 70 years or older, at least two PSA tests performed within an interval of 1-3 months are greater than 5.5ng/ml and the free/total PSA ratio is less than 25%. NB: Relevant family history is a first degree relative with prostate cancer or suspected of carrying a BRCA 1, BRCA 2 mutation.
(*)http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/Factsheet-MRIProstate
3. Patient has provided written informed consent for participation in trial
4. In the opinion of the investigator, willing and able to comply with required study procedures
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known diagnosis of prostate cancer.
2. Previous prostate biopsy within 3 years of recruitment. A transurethral resection of the prostate performed for primary purpose of alleviating lower urinary tract symptoms is considered acceptable.
3. Previous mpMRI prostate within 3 years of recruitment.
4. History of other active malignancy within the last 3 years, with the exception of nonmelanoma skin cancer or melanoma in-situ.
5. Any absolute contra-indication to 3T mpMRI prostate, or previous history of total hip joint replacement.
6. Significant intercurrent morbidity that, in the judgement 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
Other
Other design features
A prospective single arm paired comparison study
Phase
Phase 3
Type of endpoint(s)
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 first phase of the trial, determined by funding, is a pilot of 60-100 patients to demonstrate feasibility.

If the pilot phase is successful, defined as timely recruitment of patients with acceptable adverse events, further funding will be sought to continue the trial to an ideally powered sample size. To this end, a sample size of 172 (all patients receiving both diagnostic imaging arms) will achieve a power of 0.80 using the following pragmatic assumptions:
1. 50% of men who undergo prostate biopsy will be diagnosed with prostate cancer
2. mpMRI prostate has a true underlying AUC of 0.7, consisting of a sensitivity of 0.7 and a specificity of 0.7. (so expected proportion = 0.35)
3. PSMA-PET/CT has a true underlying AUC of 0.9, consisting of a sensitivity of 0.9 and a specificity of 0.9. a. The proportion of cases (PSMA PET/CT as opposed to mpMRI) is 20% higher b. absolute margin of improvement is 7% (0.35 to 0.42), to declare PSMA-PET/CT is superior
4. Estimated correlation between the two tests is 80%
5. Two-sided type I error of 5%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 15820 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 15821 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [3] 15822 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 15823 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [5] 15824 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment postcode(s) [1] 29256 0
3065 - Fitzroy
Recruitment postcode(s) [2] 29257 0
3050 - Parkville
Recruitment postcode(s) [3] 29258 0
2076 - Wahroonga
Recruitment postcode(s) [4] 29259 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 304422 0
Hospital
Name [1] 304422 0
St Vincent's Hospital Melbourne
Address [1] 304422 0
41 Victoria Parade, Fitzroy, VIC 3065
Country [1] 304422 0
Australia
Funding source category [2] 304913 0
Commercial sector/Industry
Name [2] 304913 0
Cyclotek (Aust) Pty Ltd
Address [2] 304913 0
38 Clements Ave, Bundoora VIC 3083
Country [2] 304913 0
Australia
Funding source category [3] 304914 0
Commercial sector/Industry
Name [3] 304914 0
GE HealthCare
Address [3] 304914 0
32 Phillip St, Parramatta NSW 2150
Country [3] 304914 0
Australia
Primary sponsor type
Individual
Name
Mr Lih-Ming Wong
Address
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 305258 0
None
Name [1] 305258 0
Address [1] 305258 0
Country [1] 305258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304857 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 304857 0
41 Victoria Parade, Fitzroy, VIC 3065
Ethics committee country [1] 304857 0
Australia
Date submitted for ethics approval [1] 304857 0
03/12/2019
Approval date [1] 304857 0
04/02/2020
Ethics approval number [1] 304857 0
HREC 230/19

Summary
Brief summary
The purpose of this study is to compare a new imaging technique (called 18F-DCPYL-PET/CT) to standard imaging.

Who is it for?
You may be eligible for this study if you are a male aged 18 or older and are due for imaging to see if you have prostate cancer.

Study details
All participants in this study will have two scans. One is a multi-parametric magnetic resonance imaging (mpMRI) scan, which is the standard imaging technique used. The other scan is a Positron Emission Tomography (PET) scan, which will be combined with a technique called computed tomography (CT). The PET scan required injection of a chemical called 18F-DCPYL, using a needle in the arm. Researchers will use the results of these scans to see if the 18F-DCPYL scan is as useful as the mpMRI. As part of the study, participants will consent to access medical records, in addition to the scans.

It is hoped this research will demonstrate the 18F-DCPYL scan can improve our ability to detect prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98426 0
Mr Lih-Ming Wong
Address 98426 0
St Vincent's Hospital Melbourne
Suite 2.5, 141 Grey St, East Melbourne, Victoria 3002
Country 98426 0
Australia
Phone 98426 0
+61394195290
Fax 98426 0
+61394163034
Email 98426 0
lih-ming.wong@svha.org.au
Contact person for public queries
Name 98427 0
Mr Alexandar Christov
Address 98427 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, VIC 3065
Country 98427 0
Australia
Phone 98427 0
+61394195290
Fax 98427 0
+61394163034
Email 98427 0
alexandar.christov2@svha.org.au
Contact person for scientific queries
Name 98428 0
Mr Lih-Ming Wong
Address 98428 0
St Vincent's Hospital Melbourne
Suite 2.5, 141 Grey St, East Melbourne, Victoria 3002
Country 98428 0
Australia
Phone 98428 0
+61394195290
Fax 98428 0
+61394163034
Email 98428 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
Individual participant data will be de-identified and pooled to ensure anonymity of study participants.
Only group data will be used in any analysis and publications arising from this trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results