Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001530213
Ethics application status
Approved
Date submitted
4/09/2018
Date registered
13/09/2018
Date last updated
3/03/2021
Date data sharing statement initially provided
20/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
IMPPORT Trial: Impact of 18F-DCFPyL PET scanning in patients undergoing post-prostatectomy Radiotherapy
Scientific title
IMPPORT Trial: Impact of 18F-DCFPyL PET scanning in patients undergoing post-prostatectomy Radiotherapy
Secondary ID [1] 295990 0
Nil
Universal Trial Number (UTN)
Trial acronym
IMPPORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 309504 0
Condition category
Condition code
Cancer 308338 308338 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
18FDCPyL is an investigational radioactive diagnostic imaging agent indicated for positron emissiontomography (PET) in patients with cancer where knowledge of the distribution of Prostate SpecificMembrane Antigen (PSMA) throughout the body.
To assess the role and impact of a new imaging scan, 18FDCPyLPET in patients referred for
salvage radiotherapy (radiation treatment when prostate cancer has recurred) following radical prostatectomy forprostate cancer. 18FDCPyLPET/CT has previously shown to provide high resolution imagery in targeted areas
Participants will have an 18FDCPyLPET/CT scan, in which the results will determine what management pathway best suits them.
Participants will be required to have 1 PET/CT scan this scan will take approximately 2 hours. The PET imaging will be performed in the imaging department by qualified Nuclear Medicine Specialists
250 MBq +/50 MBq, depending on patient weight and activity provided on day of scan
Intervention code [1] 312317 0
Treatment: Other
Intervention code [2] 312391 0
Early detection / Screening
Intervention code [3] 312392 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307320 0
The impact of PET/CT will be based on change in treatment intent compared to 1) intent prior to any imaging performed and 2) intent based on the diagnostic CT result
Grading will be similar to the system reported by van Leeuwen et al: (28) - 1) None, 2) Moderate and 3) Major, with an addition of classification of ‘Ignored’
Timepoint [1] 307320 0
36 Months post enrolment
Secondary outcome [1] 351458 0
To compare the detection of disease using 18F-DCFPyL PET/CT compared to diagnostic computer tomography specially in pelvic nodal (N) or metastatic disease (M)
Kaplin Meier time to event actuarial curves will be constructed to examine disease progression or nodal/distant failure
Timepoint [1] 351458 0
36 months post enrolment

Eligibility
Key inclusion criteria
Men being referred and suitable for radiotherapy to the prostate-bed and/or pelvis.
Biochemical recurrence defined as PSA greater than 0.2 ng/mL and less than2.0 ng/mL
Prior radical prostatectomy with or without pelvic lymph node dissection
Staging immediately prior to prostatectomy showed no evidence of metastatic disease: TanyNanyM0. Any prior imaging permitted including CT, bone scan and previous functional imaging scans.
Pathological staging following prostatectomy: pTany, pNany
Histopathology of Acinar adenocarcinoma or ductal carcinoma
Age over 18 years
PSA within 4 weeks of PET/CT
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Established distant metastases
No prior pelvic or prostate bed radiotherapy
Prostate cancer with significant sarcomatoid or neuroendocrine small cell components
Significant intercurrent morbidity that, in the judgement of the investigator, would limit compliance with the study protocols
Current androgen deprivation therapy or anti-androgen therapy

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
20/12/2019
Actual
1/06/2020
Date of last data collection
Anticipated
20/12/2023
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23876 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 300584 0
Other Collaborative groups
Name [1] 300584 0
GenesisCare Cancer Care Research
Country [1] 300584 0
Australia
Primary sponsor type
Other Collaborative groups
Name
GenesisCare Cancer Care Research
Address
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 300079 0
None
Name [1] 300079 0
Address [1] 300079 0
Country [1] 300079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301372 0
St Vincents Hopsital (Melbourne) Human Research Ethics Committee{EC00343}
Ethics committee address [1] 301372 0
Ethics committee country [1] 301372 0
Australia
Date submitted for ethics approval [1] 301372 0
20/03/2018
Approval date [1] 301372 0
29/05/2018
Ethics approval number [1] 301372 0
HREC/18/SCHM/130

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

Contacts
Principal investigator
Name 86786 0
Dr Michael Ng
Address 86786 0
GenesisCare
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country 86786 0
Australia
Phone 86786 0
+61 3 94098000
Fax 86786 0
Email 86786 0
[email protected]
Contact person for public queries
Name 86787 0
Angela Benson
Address 86787 0
GenesisCare
Cancer Care Research
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country 86787 0
Australia
Phone 86787 0
+61 439 731 954
Fax 86787 0
Email 86787 0
[email protected]
Contact person for scientific queries
Name 86788 0
Michael Ng
Address 86788 0
GenesisCare
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country 86788 0
Australia
Phone 86788 0
+61 3 94098000
Fax 86788 0
Email 86788 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?

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
SourceTitleYear of PublicationDOI
EmbasePatterns of disease detection using [18F]DCFPyL PET/CT imaging in patients with detectable PSA post prostatectomy being considered for salvage radiotherapy: a prospective trial.2021https://dx.doi.org/10.1007/s00259-021-05354-8
EmbaseRe-defining 18F-DCFPyl prostate-specific membrane antigen positron emission tomography detected local recurrence from radical prostatectomy histopathology.2023https://dx.doi.org/10.1111/bju.16085
N.B. These documents automatically identified may not have been verified by the study sponsor.