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Trial registered on ANZCTR


Registration number
ACTRN12622000124730
Ethics application status
Approved
Date submitted
22/11/2021
Date registered
27/01/2022
Date last updated
27/01/2022
Date data sharing statement initially provided
27/01/2022
Date results information initially provided
27/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of 18F Prostate Specific Membrane Antigen (PSMA) PET-MRI fusion in the Local Characterisation of Low Grade Prostate Cancer
Scientific title
18F Prostate Specific Membrane Antigen (PSMA) PET/CT-MRI fusion evaluation of high grade multi-parametric MRI abnormalities in patients with suspected prostate cancer.
Secondary ID [1] 305220 0
None
Universal Trial Number (UTN)
Trial acronym
PMEHGMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 323492 0
Condition category
Condition code
Cancer 321059 321059 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is no interventional agent being used in this investigation. The investigation involves changing the order of standard imaging investigations currently used by Urologists to investigate prostate cancer in men from MRI --> Biopsy --> PET/CT scan to MRI --> PET/CT scan --> +/- biopsy. This is a practice which is already being done at the discretion of the Urologist and this study will evaluate if the current recommendations in professional guidelines are in fact up to date and still appropriate.

The mpMRI and PET scans approximately take 40 and 60 minutes on average, respectively. The mpMRI will be reported by local Radiologists according to the Prostate Imaging-Reporting and Data System, version 2 (PI-RADS v2), with each lesion categorized on a scale from 1 to 5. Location of suspicious areas (scoring of greater than or equal to 3) will warrant descriptions of location and size to allow for targeted biopsies as per standard of care. Where a PI-RADS 4 lesion of at least 10mm in one dimension, or a PI-RADS 5 lesion, is identified, subjects will be invited to undergo a PSMA PET-CT scan as part of the trial.

PSMA PET/CT: Up to 350MBq of 18F-DCFPyL PSMA will be administered to each patient (calculated according to body weight) as a slow bolus injection (over approximately 30 seconds) by a Radiology specialist nurse. A PET-CT scan will be undertaken at 90 minutes post injection from the vertex to the thighs with a non-contrast-enhanced low dose CT scan post tracer injection. 18F-PSMA PET images will be clinically reported at a “per lesional” level (after fusion with MRI) and also at a “per patient” level for whole body staging.

The PET/CT will occur within 2 weeks of the MRI and if a biopsy is required, this will occur with 1-2 weeks of the PET Scan or earlier, depending on the Urologists' operative list. Each patient's participation in the trial will be recorded on their referral forms for imaging and biopsy and concerned staff will be informed of booking and arrival dates for patients. Staff involved will be trained in trial protocol and relevant staff in Radiology and Nuclear Medicine will maintain their own checklists and communicate with other staff via secure email. The Principal Investigator will maintain the main checklist and participant database.
Intervention code [1] 321617 0
Diagnosis / Prognosis
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328896 0
Composite Primary outcome 1: Determine the proportion of Prostate Imaging - Reporting and Data System (PI-RADS) 4 lesion(s) at least 10mm, and/or PIRADS 5 lesion(s), on mpMRI prostate that are PSMA avid
Timepoint [1] 328896 0
After each participant undergoes a prostate MRI, it will be read by a Radiologist to determine the need for a PET/CT which will then be read by the Nuclear Medicine Specialist and fused with the MRI to assess PI-RADS 4 at least 10 mm or PIRADS-5 lesion(s) that are PSMA avid.
Primary outcome [2] 328897 0
Proportion of high grade prostate cancers that are “mpMRI-occult” that were detected on subsequent PSMA PET-MRI fusion.
Timepoint [2] 328897 0
After participants undergo PSMA-PET/CT and subsequent fusion of their MRI and PET is undertaken. This could be cumulative at the end of the study or on rolling basis as participants are scanned, at the discretion of the Nuclear Medicine Specialist and depending on their workload.
Primary outcome [3] 328898 0
SUV max of biopsy-proven high grade prostate cancers, divided into zonal locations
Timepoint [3] 328898 0
cumulative SUV max data assessed at the completion of the study
Secondary outcome [1] 400822 0
Composite outcome: Determine the proportion of PI-RADS 4 lesion(s) at least 10mm or PI-RADS 5 lesion(s) confirmed to have high grade prostate cancer on biopsy,
Timepoint [1] 400822 0
Cumulative biopsy data will be assessed at the completion of the study.
Secondary outcome [2] 400823 0
Composite outcome: In the subset of men proceeding to radical prostatectomy, determine histopathologic concordance of identified lesions on mpMRI and PSMA PET/MRI fusion and proportion of Gleason grade change from biopsy,
Timepoint [2] 400823 0
Cumulative biopsy and prostatectomy data will be assessed at the completion of the study.
Secondary outcome [3] 402700 0
Change in SUV max at 60, 90 and 120 minutes of PET/CT
Timepoint [3] 402700 0
60, 90 and 120 minutes of PET/CT

Eligibility
Key inclusion criteria
• Men greater than or equal to 50 years old
• Elevated PSA, more than 3.0ng/mL on 2 or more occasions with no other cause identified or an abnormal Digital Rectal Examination (DRE) that remains organ confined, i.e. cT2
• No previously diagnosed PCa
• No previous prostate biopsies
• Undergoing mpMRI and considering prostate biopsy
• Ability to give written informed consent, participate in and comply with study
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Previous diagnosis of PCa
• Previous prostate biopsies
• Inability/ incapacity to provide own consent
• PSA more than 20ng/ml
• more than or equal to cT3 on DRE
• Previous TURP
• Contraindication to MRI, including but not restricted to:
o Pacemaker or other electronic implant
o Allergy or contraindication to MRI contrast, e.g. renal failure (eGFR less than 30mL/min)
o Shrapnel, tattoos, non-removable body piercings (relative contraindication)

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
Actual
22/03/2021
Date of last data collection
Anticipated
Actual
22/03/2021
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20503 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 35280 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 309597 0
Commercial sector/Industry
Name [1] 309597 0
Astra Zeneca
Country [1] 309597 0
Australia
Funding source category [2] 309644 0
Commercial sector/Industry
Name [2] 309644 0
Cyclotek
Country [2] 309644 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cyclotek
Address
Cyclotek Theranostics Pty Ltd
38 Clements Avenue
Bundoora Victoria 3083 Australia
Country
Australia
Secondary sponsor category [1] 310608 0
Commercial sector/Industry
Name [1] 310608 0
Astra Zeneca
Address [1] 310608 0
47 Talavera Road North, Ryde New South Wales 2113
Country [1] 310608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309373 0
Adventist Health Care Human Research Ethics Committee
Ethics committee address [1] 309373 0
Level 4 Clifford Tower
Administration Corridor, Room 10
185 Fox Valley Road
WAHROONGA NSW 2076
Ethics committee country [1] 309373 0
Australia
Date submitted for ethics approval [1] 309373 0
Approval date [1] 309373 0
01/05/2020
Ethics approval number [1] 309373 0

Summary
Brief summary
The finding of a PI-RADS 4 or 5 lesion on mpMRI carries a high index of suspicion, and probability, of the lesion being clinically significant PCa. However, the sensitivity and specificity is not sufficient to make a definitive diagnosis of PCa without biopsy. Early literature shows that PSMA PET-MRI is superior to mpMRI alone at detecting clinically significant prostate cancer. A positive PSMA PET-MRI lesion is therefore even more likely to correlate with histopathological confirmation of clinically significant PCa. Given that size of the lesion can impact on the successful confirmatory sampling, and detection on PSMA PET, a minimum size of 10mm would make it highly unlikely that the lesion would be missed on biopsy or PET scan. This work has the potential to identify a select group of men who could potentially proceed to definitive surgical treatment without the need for prostate biopsy.

Study Details
All participants in this study will undergo a mpMRI which is a standard of care investigation, and an 18F-PSMA PET-CT as the research investigation after which a transperineal prostate biopsy of identified lesions will take place as is standard of care,

All participants will be recruited via clinics of and by Urologists with scans and biopsies performed at the SAH. Within 2 weeks post biopsy; participants will follow-up with their urologist for discussion of results.
For the subset of patients proceeding to radical prostatectomy, histopathological concordance with identified lesions on each of the imaging modalities will be analysed. The proportion of men with change in Gleason grade group following radical prostatectomy will also be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113926 0
Prof Henry Woo
Address 113926 0
Suite 406, San Clinic
185 Fox Valley Road
Wahroonga NSW 2076
Country 113926 0
Australia
Phone 113926 0
+61 2 90527586
Fax 113926 0
Email 113926 0
[email protected]
Contact person for public queries
Name 113927 0
Hadia Khanani
Address 113927 0
Sydney Adventist Hospital
185 Fox Valley Road
Wahroonga NSW 2076
Country 113927 0
Australia
Phone 113927 0
+61 411 521 970
Fax 113927 0
Email 113927 0
[email protected]
Contact person for scientific queries
Name 113928 0
Henry Woo
Address 113928 0
Suite 406, San Clinic
185 Fox Valley Road
Wahroonga NSW 2076
Country 113928 0
Australia
Phone 113928 0
+61 2 90527586
Fax 113928 0
Email 113928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patients' mpMRI and PSMA PET CT findings (de-identifiable)
When will data be available (start and end dates)?
Following publication with no end date decided
Available to whom?
to the public via a publication
Available for what types of analyses?
none specific
How or where can data be obtained?
upon request from authors of the publication. The authors have the right to accept or reject such requests. emails for requests to be sent to [email protected] (Research Fellow) overseeing this trial


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.