COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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

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

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
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Address [1] 300584 0
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country [1] 300584 0
Primary sponsor type
Other Collaborative groups
GenesisCare Cancer Care Research
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Secondary sponsor category [1] 300079 0
Name [1] 300079 0
Address [1] 300079 0
Country [1] 300079 0

Ethics approval
Ethics application status
Ethics committee name [1] 301372 0
St Vincents Hopsital (Melbourne) Human Research Ethics Committee{EC00343}
Ethics committee address [1] 301372 0
41 Victoria Parade, Fitzroy Victoria 3065
Ethics committee country [1] 301372 0
Date submitted for ethics approval [1] 301372 0
Approval date [1] 301372 0
Ethics approval number [1] 301372 0

Brief summary
The purpose of this study is to see whether the use of a particular type of PET scan will improve detection rates of cancer, and improve treatment management.

Who is it for?
You may be eligible for this study if you are aged over 18 and have been referred for radiotherapy after a prostatectomy.

Study details
All participants in this study will be required to undergo a PET/CT scan and a diagnostic CT Chest/Abdomen Pelvis
You will also be asked to fill out a quality of life Questionnaire. before and after commencing radiotherapy. You will be reviewed as part of your routine care with a routine blood test which will monitor your PSA levels at these visits you will be asked to complete a quality of life Questionnaire.

It is hoped this research will determine if the use of PET scanning in treatment planning and how it influences radiation treatment planning in patients will improve treatment outcomes for patients with prostate cancer.
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary