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Trial registered on ANZCTR


Registration number
ACTRN12621001185853p
Ethics application status
Submitted, not yet approved
Date submitted
29/06/2021
Date registered
3/09/2021
Date last updated
3/09/2021
Date data sharing statement initially provided
3/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study to assess additional benefit of Fluorodeoxyglucose (FDG) PET scanning after staging with Prostate Specific Membrane Antigen (PSMA) PET for newly diagnosed high grade prostate cancer
Scientific title
A prospective, multi-centre, single-arm diagnostic phase 2 open-label trial to assess additional diagnostic benefit of FDG PET/CT imaging after staging with PSMA PET for newly diagnosed high grade prostate cancer prior to treatment
Secondary ID [1] 304646 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FIND Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 322591 0
Condition category
Condition code
Cancer 320205 320205 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo usual work up prior to and after prostate cancer diagnosis. PSMA PET will be completed prior to registration. The intended initial management plan will be documented at time of registration (baseline) by the referring clinician.

18F-FDG PET imaging is expected to be completed within 21 days following registration. Researchers will be present at time of imaging commencement to register attendance (adherence). 18F-FDG PET imaging will be completed according to standard protocol as practiced on a daily basis at the RBWH. Participants will present to the Herston Imaging Research Facility (HIRF) and an IV cannula will be placed before injection of a bolus of FDG tracer (4.25MBq/kg, minimum 90MBq, maximum 310MBq). The patient will rest for the standard uptake time (1 hour) post FDG injection. At the end of the uptake period the patient will be moved to the PET/CT scanner where scanning will commence. The PET/CT acquisition will last approximately 30 minutes.

The findings will be recorded for study purposes and provided to the referring clinician who may modify patient management or seek additional information based on the result. An updated management plan according to clinician direction will be submitted based on all information up at the 1 month time-point.
Intervention code [1] 320994 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328078 0
Diagnostic accuracy of FDG PET and PSMA-PET/CT for determining the presence or absence of pelvic nodal or distant metastases. Diagnostic accuracy will be defined by comparing PET findings to a composite endpoint based on follow-up data (adapted from ProPSMA trial, Hofman et al. Lancet 395(10231):1208-1216).
Timepoint [1] 328078 0
12 months after registration
Secondary outcome [1] 397514 0
Change in management intent (curative or palliative) will be assessed by audit of patient medical records
Timepoint [1] 397514 0
At 1 month after FDG PET
Secondary outcome [2] 397515 0
Predictors of early oncological outcomes (PSA response, progression endpoints) relative to diagnostic findings for each PET imaging modality
Timepoint [2] 397515 0
12 months after registration
Secondary outcome [3] 397516 0
Effect of FDG PET imaging and results on Quality of Life, measured according to EORTC Quality of Life Questionnaire for Cancer patients (QLQ-C30) instrument.
Timepoint [3] 397516 0
Registration, immediately after FDG PET scan and 1 month, 6 months, 12 months after FDG PET scan
Secondary outcome [4] 400549 0
Addition or removal of particular treatment modality will be assessed by audit of patient medical records
Timepoint [4] 400549 0
6 months after FDG PET
Secondary outcome [5] 400552 0
Change in initial treatment method (e.g. change in surgery, radiation therapy or systemic therapy approach, extent or duration) will be assessed by audit of patient medical records
Timepoint [5] 400552 0
1 month after FDG PET
Secondary outcome [6] 400555 0
Patient experience will be measured according to a shortened version of the Study Participant Feedback Questionnaire (SPFQ)
Timepoint [6] 400555 0
Registration, immediately after FDG PET scan and 1 month after FDG PET scan

Eligibility
Key inclusion criteria
1. Men aged 18 years or older
2. Untreated, histologically confirmed prostate cancer
3. High risk disease according to clinical features, at least one of;
- Serum PSA >20ng/ml
- Biopsy Gleason Grade 4+4 or higher / Grade Group 4 or higher
- cT3/4 according to digital rectal examination (DRE) and/or magnetic resonance imaging (MRI)
4. Negative, Localised or metastatic disease according to PSMA PET/CT
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
6. Adequate haematological, renal, hepatic and pulmonary functions
7. Written informed consent provided
8. Willingness and ability to comply with all study protocols
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. prior treatment with radiotherapy or systemic therapies (e.g. androgen deprivation therapy, chemotherapy) for prostate cancer
2. history of other active malignancy within last 2 years (except non-melanoma skin cancer and superficial bladder cancer)
3. severe active co-morbidity or other barrier to completing study processes

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
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)
QLD
Recruitment hospital [1] 19826 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 19827 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 19828 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 19829 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 34514 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 34515 0
4029 - Herston
Recruitment postcode(s) [3] 34516 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 34517 0
4020 - Redcliffe
Recruitment postcode(s) [5] 34518 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 309008 0
Charities/Societies/Foundations
Name [1] 309008 0
Royal Brisbane and Women's Hospital Foundation
Address [1] 309008 0
Block 20 Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4006
Country [1] 309008 0
Australia
Funding source category [2] 309011 0
Other
Name [2] 309011 0
Herston Imaging Research Facility
Address [2] 309011 0
Level 3, Building 71/918, Royal Brisbane & Women's Hospital, Herston QLD 4029
Country [2] 309011 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service
Address
Level 14 Block 7
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 309943 0
None
Name [1] 309943 0
-
Address [1] 309943 0
-
Country [1] 309943 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308895 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 308895 0
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Ethics committee country [1] 308895 0
Australia
Date submitted for ethics approval [1] 308895 0
14/05/2021
Approval date [1] 308895 0
Ethics approval number [1] 308895 0

Summary
Brief summary
The primary purpose of this trial is to evaluate whether FDG PET is helpful for clinicians treating men with newly diagnosed aggressive prostate cancer (according to tissue histology) and staged with PSMA PET.

Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with aggressive prostate cancer (high risk features) and have not had treatment to date, but you may be planning to undergo surgery, radiotherapy or other treatments.

Study details: All participants enrolled in this trial will undergo a FDG PET/CT scan. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course.

The accuracy of the PET scans will be determined according to follow-up information available up to 12 months after entering the study. The findings of the scans will be investigated for their ability to predict future cancer outcomes. Patient reported outcomes (PROs) as to how the scans and subsequent treatment affect enrolled participants will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112254 0
Dr Matthew Roberts
Address 112254 0
Department of Urology
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country 112254 0
Australia
Phone 112254 0
+61 7 3646 3197
Fax 112254 0
+61 7 3646 1711
Email 112254 0
matthew.roberts@health.qld.gov.au
Contact person for public queries
Name 112255 0
Dr Matthew Roberts
Address 112255 0
Department of Urology
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country 112255 0
Australia
Phone 112255 0
+61 7 3646 3197
Fax 112255 0
+61 7 3646 1711
Email 112255 0
matthew.roberts@health.qld.gov.au
Contact person for scientific queries
Name 112256 0
Dr Matthew Roberts
Address 112256 0
Department of Urology
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country 112256 0
Australia
Phone 112256 0
+61 7 3646 3197
Fax 112256 0
+61 7 3646 1711
Email 112256 0
matthew.roberts@health.qld.gov.au

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 other documents available
Summary results
No Results