Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000783628
Ethics application status
Approved
Date submitted
19/05/2014
Date registered
22/07/2014
Date last updated
24/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study
Scientific title
Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study
Secondary ID [1] 284625 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localized Prostate Cancer 291939 0
Condition category
Condition code
Cancer 292291 292291 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand
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/5 micrograms. The infusion will last 5 minutes and 1 infusion is required.

For MP MRI, the participants will be injected with a contrast agent (or “dye”). The whole scan would take about 30 to 40 minutes. A medication called Buscopan or Glucagon is injected into the blood stream to slow bowel movement, since a moving bowel can reduce the quality of the image. This scan will be undertaken once in the study.

For PET, the [68Ga]Gallium-labelled Prostate-specific membrane antigen ligand PSMA ligand will be injected into the blood stream. After 90 minutes, the participants will be placed in the PET scanner and the scan will begin (scanning takes ~30 minutes). A low dose whole-body computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan. This scan will be undertaken once in the study.

For whole-mount pathology analysis, participants do not need to do anything. The prostate tissue will be collected after surgery as part of their clinical managements. In addition to a standard pathology report to the surgeon, specific pathology reports will be reported to the study team for analysis.
Intervention code [1] 289409 0
Diagnosis / Prognosis
Intervention code [2] 289788 0
Early detection / Screening
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292157 0
Detection of local prostate cancer foci by PET/CT scan and multi-parametric MRI
Timepoint [1] 292157 0
Outcome will be assessed once. After the imaging studies have been performed, and the final specimen retrieved, final analysis will be performed to correlate the results. There is no specific point time for the primary outcome.
Secondary outcome [1] 308325 0
Correlation of the intensity of 68Ga-HBED-CC uptake with histopathologic Gleason Grade, tumour volume and tumour grade
Timepoint [1] 308325 0
Outcome will be assessed once. After the imaging studies have been performed, and the final specimen retrieved, final analysis will be performed to correlate the results. There is no specific point time for the outcome.

Eligibility
Key inclusion criteria
1.Male patients pathologically diagnosed with localized prostate cancer, awaiting prostatectomy
2. The time interval between last prostate biopsy and planned MP-MRI or planned 68Ga- HBED-CC PET must be not less than 8 weeks
3. No known problems with peripheral intravenous or central line access
4. Able to provide informed signed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age under 18 years
2. Prior pelvic external beam radiation therapy or brachytherapy, prior chemotherapy, prior hormonal or radiation therapy for prostate cancer
3. Administered a radioisotope within 5 physical half-lives prior to study enrolment
4. Treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
5. Hemorrhagic cystitis or active prostatitis
6. Unable to lie flat during or unable to tolerate MP MRI or PET
7. Prior history of any other malignancy within last 2 years
8. Contraindication to MRI or MRI contrast agent or PET scan or [68Ga]gallium-labelled PSMA ligand
9. Claustrophobia not manageable by oral sedatives ie Temazepam
10. Moderate to severe rectal inflammation
11. Previous rectal surgery that will affect prostate imaging
12. MRI incompatible pacemakers
13. Metallic implants or pumps which are MRI incompatible
14. Renal impairment or hemodialysis.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289253 0
Charities/Societies/Foundations
Name [1] 289253 0
Cyril Gilbert Testimonial Fund, Gallipoli Medical Research Foundation
Country [1] 289253 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2, George Street, Brisbane, QLD 4122, Australia
Country
Australia
Secondary sponsor category [1] 287926 0
None
Name [1] 287926 0
Address [1] 287926 0
Country [1] 287926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291019 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 291019 0
Ethics committee country [1] 291019 0
Australia
Date submitted for ethics approval [1] 291019 0
Approval date [1] 291019 0
11/12/2013
Ethics approval number [1] 291019 0
EC00161
Ethics committee name [2] 291020 0
Royal Brisbane ad Women’s Hospital Human Research Ethics Committee
Ethics committee address [2] 291020 0
Ethics committee country [2] 291020 0
Australia
Date submitted for ethics approval [2] 291020 0
Approval date [2] 291020 0
29/01/2014
Ethics approval number [2] 291020 0
EC00172
Ethics committee name [3] 291021 0
Metro South Health service District Human Research Ethics Committee
Ethics committee address [3] 291021 0
Ethics committee country [3] 291021 0
Australia
Date submitted for ethics approval [3] 291021 0
Approval date [3] 291021 0
29/01/2014
Ethics approval number [3] 291021 0
EC00167
Ethics committee name [4] 291022 0
Queensland University of Technology
Ethics committee address [4] 291022 0
Ethics committee country [4] 291022 0
Australia
Date submitted for ethics approval [4] 291022 0
Approval date [4] 291022 0
01/04/2014
Ethics approval number [4] 291022 0
EC00171

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

Contacts
Principal investigator
Name 48522 0
Dr Peter Heathcote
Address 48522 0
Dr Peter Heathcote
Brisbane Urology Clinic
Level 11, BMM Place, 135 Wickham Terrace, Brisbane, QLD 4000
Country 48522 0
Australia
Phone 48522 0
+61 7 38303310 (for Brisbane, Australia)
Fax 48522 0
+61 7 38303399
Email 48522 0
heathcote@birsbaneurologyclinic.com.au
Contact person for public queries
Name 48523 0
Peter Heathcote
Address 48523 0
Dr Peter Heathcote
Brisbane Urology Clinic
Level 11, BMM Place, 135 Wickham Terrace, Brisbane, QLD 4000
Country 48523 0
Australia
Phone 48523 0
+61 7 38303310 (for Brisbane, Australia)
Fax 48523 0
+61 7 38303399
Email 48523 0
heathcote@birsbaneurologyclinic.com.au
Contact person for scientific queries
Name 48524 0
Peter Heathcote
Address 48524 0
Dr Peter Heathcote
Brisbane Urology Clinic
Level 11, BMM Place, 135 Wickham Terrace, Brisbane, QLD 4000
Country 48524 0
Australia
Phone 48524 0
+61 7 38303310 (for Brisbane, Australia)
Fax 48524 0
Email 48524 0
heathcote@birsbaneurologyclinic.com.au

No information has been provided regarding IPD availability


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
No additional documents have been identified.