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Trial registered on ANZCTR


Registration number
ACTRN12616000186459
Ethics application status
Approved
Date submitted
18/12/2015
Date registered
12/02/2016
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study – Identification of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy
Scientific title
Feasibility study – Identification of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy
Secondary ID [1] 287037 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 295504 0
Condition category
Condition code
Cancer 295763 295763 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand (68Ga-PSMA)
Glu-NH-CO-NH-Lys-(Ahx)-[68Ga-N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'- diacetic acid]
The dosage form is intravenous (IV) solution. The strength is 150MBq. One infusion is needed for the scan. The infusion of the 68Ga-PSMA ligands takes about 45 mins. Then, 68Ga-PSMA PET/MR scan will be performed. The scan will take 1-2 hours..
There will be no additional scans for this study unless they are clinically required.
If the PSMA PET/MR scans demonstrate a lesion, the participants may undergo biopsy or surgical excision as part of clinical management. The decision of biopsy or surgical excision will be made between the participants, clinicians and members of Prostate Cancer Multi-Disciplinary Team Clinic. The specimens will be taken for pathology analysis for clinical management. They will also be cultured in laboratory for experimental uses.
Intervention code [1] 292243 0
Diagnosis / Prognosis
Comparator / control treatment
Other standard imaging modality available, e.g.staging CT, bone scan and standard MRI of the recurrence site which is needed for clinical management.
Control group
Active

Outcomes
Primary outcome [1] 295474 0
The accuracy (sensitivity and specificity) of PSMA PET/MRI in detecting metastatic or locally recurrent lesion in participants with biochemical recurrence post primary treatment of prostate cancer. The results of the PSMA PET/MRI scan will be compared to other imaging modality available e.g. staging CT, bone scan or standard MRI of the recurrence site which is needed for clinical management. The results of the PSMA PET/MRI scan will also be compared to the histology report of the PSMA PET/MRI positive specimen if there is a clinical need to take out the PET/MRI positive tissue.
Timepoint [1] 295474 0
After the PSMA PET/MRI has been performed or the PSMA PET/MRI positive specimens have been histopathologically analysed.
Secondary outcome [1] 315659 0
The utility of hybrid PET/MRI scan compared to standard imaging modalities in altering the management of patients from the standard of care by review of medical records and by interview with treating physician.
Timepoint [1] 315659 0
At the end of the study

Eligibility
Key inclusion criteria
1. Male patients with pathologically diagnosed prostate cancer
2. Biochemical Recurrence as defined:
a. PSA > 0.2ng/ml on at least 2 occasions post radical prostatectomy
b. PSA 2.0ng/ml above nadir 2 years post radiotherapy
3. History of primary treatment for prostate cancer no sooner than 3 months post-surgery and 2 years post radiotherapy
4. No known problems with peripheral intravenous or central line access
5. Able to provide informed signed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age under 18 years
2. Administered a radioisotope within 5 physical half-lives prior to study enrolment
3. Unable to lie flat during or unable to tolerate PET/MRI
4. Prior history of any other malignancy within last 2 years
5. Contraindication to PET scan or [68Ga]Gallium-labelled PSMA ligand
6. Claustrophobia not manageable by oral sedatives i.e. Temazepam
7. Renal impairment or haemodialysis.
8. Contraindication to biopsy of identified lesion
9. Contraindication to MRI such as implantable medical devices
10. Body weight above 150kg or axial diameter larger than 60cm

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 4000 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 4001 0
Greenslopes Private Hospital - Greenslopes

Funding & Sponsors
Funding source category [1] 291590 0
Hospital
Name [1] 291590 0
The Private Practice Trust Fund, Princess Alexandra Hospital
Address [1] 291590 0
Centres for Health Research
Level 7, Translational Research Institute, 37 Kent Street,
Woolloongabba QLD 4102 Australia
Country [1] 291590 0
Australia
Funding source category [2] 291591 0
Other Collaborative groups
Name [2] 291591 0
ANZUP Cancer Trial Group Ltd
Address [2] 291591 0
Level 6, Lifehouse Building, 119-143 Missenden Road, Camperdown NSW 2050 Australia
Country [2] 291591 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2, George Street, Brisbane, QLD 4122
Country
Australia
Secondary sponsor category [1] 290264 0
None
Name [1] 290264 0
Address [1] 290264 0
Country [1] 290264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293121 0
Metro South HREC
Ethics committee address [1] 293121 0
Level 7, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102
Ethics committee country [1] 293121 0
Australia
Date submitted for ethics approval [1] 293121 0
17/06/2015
Approval date [1] 293121 0
23/07/2015
Ethics approval number [1] 293121 0
HREC/15/QPAH/355
Ethics committee name [2] 293122 0
Greenslopes Research and Ethics Committee
Ethics committee address [2] 293122 0
Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120
Ethics committee country [2] 293122 0
Australia
Date submitted for ethics approval [2] 293122 0
28/07/2015
Approval date [2] 293122 0
11/08/2015
Ethics approval number [2] 293122 0
15/45
Ethics committee name [3] 293123 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [3] 293123 0
Level 4, 88 Musk Avenue, Kelvin Grove QLD 4059
Ethics committee country [3] 293123 0
Australia
Date submitted for ethics approval [3] 293123 0
28/07/2015
Approval date [3] 293123 0
04/09/2015
Ethics approval number [3] 293123 0
1500000647

Summary
Brief summary
The study aims to evaluate the sensitivity and specificity of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy.

Who is it for? You may be eligible to join this study if you are a male aged 18 years or above with pathologically diagnosed prostate cancer and biochemical cancer recurrence.

Study details: All participants will undergo [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI). If the scans demonstrate a lesion that is amenable to biopsy or surgery, the participants will undergo CT or ultrasound guided biopsy or surgical excision as part of their clinical management. Once a sample has been obtained, the 1st sample will be used for immunohistologic analysis and the 2nd sample will be sent for in vitro culture and further analyses. If archived tissues are available, genomic comparison of primary tumour specimens and metastatic/recurrent lesions will be performed.
At 6, 12, 18 and 24 months after the 68Ga-HBED-CC PET/MRI, relevant prostate cancer data will be used for further analysis. The information will include blood tests (Prostate Specific Antigen, Full Blood Count, Urea and Electrolytes, Calcium, Liver Function Tests), imaging (CT, PET, MR or Bone scan) and clinical history.
The novel imaging technology may identify evidence of metastatic disease, undetected by standard of care imaging. This information could alter the treatment plan potentially. The benefits of the translational aspects of the study are that a proof of principle precision medicine program may be established to attempt in vitro assessment of a patients’ tumour in a clinically relevant timeframe and to also develop novel cell lines for basic research. This may lead in the future to a larger trial utilizing such data to guide treatment decisions in men with advanced prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58566 0
Dr Ian Vela
Address 58566 0
Department of Urology, Princess Alexandra Hospital, 199 Ipswich Rd, Brisbane QLD 4102
Country 58566 0
Australia
Phone 58566 0
+61 7 31766946
Fax 58566 0
Email 58566 0
ianvela@me.com
Contact person for public queries
Name 58567 0
Dr Ian Vela
Address 58567 0
Department of Urology, Princess Alexandra Hospital, 199 Ipswich Rd, Brisbane QLD 4102
Country 58567 0
Australia
Phone 58567 0
+61 7 31766946
Fax 58567 0
Email 58567 0
ianvela@me.com
Contact person for scientific queries
Name 58568 0
Dr Ian Vela
Address 58568 0
Department of Urology, Princess Alexandra Hospital, 199 Ipswich Rd, Brisbane QLD 4102
Country 58568 0
Australia
Phone 58568 0
+61 7 31766946
Fax 58568 0
Email 58568 0
ianvela@me.com

No information has been provided regarding IPD availability
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