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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
13/09/2018
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
Gender
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
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
Address [1] 300584 0
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
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
41 Victoria Parade, Fitzroy Victoria 3065
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
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

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
Michael.Ng@genesiscare.com
Contact person for public queries
Name 86787 0
Ms Nicole Haberman
Address 86787 0
GenesisCare
Cancer Care Research
Level 5, 126 Wellington Parade
East Melbourne VIC 3002
Country 86787 0
Australia
Phone 86787 0
+61 408 737 216
Fax 86787 0
Email 86787 0
nicole.haberman@genesiscare.com
Contact person for scientific queries
Name 86788 0
Dr 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
Michael.Ng@genesiscare.com

No data has been provided for results reporting
Summary results
Not applicable