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Trial registered on ANZCTR
Registration number
ACTRN12619000088145
Ethics application status
Approved
Date submitted
5/12/2018
Date registered
22/01/2019
Date last updated
28/01/2020
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Prospective trial comparing nanoparticle-magnetic resonance lymphography and 68Ga-PSMA positron emission tomography in nodal staging of prostate cancer
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Scientific title
Prospective evaluation of lymph node imaging for the nodal staging of prostate cancer with a high risk of lymph node metastases: A prospective cohort study to determine the concordance between two imaging modalities, “Combidex” Nanoparticle-Magnetic Resonance Lymphography (Nano MRL) and 68Ga-PSMA positron emission tomography (PET)
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Secondary ID [1]
296801
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MAGNIFI Trial
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Universal Trial Number (UTN)
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Trial acronym
MAGNIFI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate cancer
310691
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Condition category
Condition code
Cancer
309390
309390
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. Men diagnosed with prostate cancer are referred to a participating urologist for a radical prostatectomy
2. The patients are consented to the study by the urologist or research assistants following fulfilment of the inclusion criteria
3. The patient is referred to a Department of Nuclear Medicine (St Vincent's Hospital Sydney or The Wesley Hospital Brisbane) where a 68Ga-PSMA (68Gallium-Prostate Specific Membrane Antigen Positron Emission Tomography: using a radioactive labelled antigen, positron emission tomography can detect lymph node metastases) PET Scan is performed
5. On the return visit, “Combidex” is administered at 2.6 mg Fe/kg intravenously after dilution in 300mls of normal saline to the patient by trained and qualified nursing staff and the patient is referred for a MRI scan (Medscan Barangaroo or The Wesley Hospital Brisbane) - this will constitute the 'MRL scan' (Nanoparticle-magnetic resonance lymphography (Combidex Nano MRL): using nanoparticle iron oxide particles as a contrast agent, magnetic resonance imaging can detect lymph node metastases at 2mm in size)
6. Radiologist and Urologist annotate suspect lymph nodes using the Pelvic Lymph Node Diagnostic Template and assign index of suspicion to each area
7. Patient undergoes radical prostatectomy including the removal of lymph nodes 7-10 days following Combidex nano-MRL
8. The prostate and the lymph nodes are sent to histology for reporting
9. Analysis:
a. Histology Vs Nano-MRL
b. Histology Vs Ga68 PSMA PET
c. Histology Vs Nano-MRL Vs Ga68 PSMA PET
10. Repeat Ga68 PSMA and Nano-MRL if not concordant with Histology within 6-8 weeks of surgery
11. Follow up Visits: The participant will have clinical follow up reviews as part of their care at 6 weeks, 3 months, 6 months, 12 months and 24 months
12. Participant will complete the Expanded Prostate Cancer Index Composite (EPIC) survey at baseline (prior to surgery), 6 weeks, 3 months, 6 months, 1 years and then yearly for a minimum of 5 years).
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Intervention code [1]
313093
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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We will compare ‘packet concordance rate’ between histology and MR Lymphography using a MRA arterial map (that can be acquired at the MRL) to locate the position of the lymph node, the 68Ga PSMA PET SCAN plus a combined evaluation, and histology.
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Assessment method [1]
308347
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Timepoint [1]
308347
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When histopathology of lymph node dissection is available.
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Secondary outcome [1]
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As part of initial longitudinal analyses quality of life (as measured using EORTC-QLQ-C30) will be evaluated using one-way ANOVA.
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Assessment method [1]
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Timepoint [1]
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As follow-up data becomes available, continuous reanalysis will occur. Initially at 3 months, then 6 months then 12 months and yearly from then until lost to follow-up or death.
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Eligibility
Key inclusion criteria
• Male, aged 18 years or over
• Confirmed adenocarcinoma of prostate and at least clinical stage T3A and/or Gleason sum greater than or equal to 4+3=7, or preoperative PSA equals 15 ng/ml and planned radical prostatectomy
• Suspected lymph node involvement pre- radical prostatectomy based on Briganti nomogram greater than or equal to 10%.
• Suitable for radical prostatectomy and pelvic lymph node dissection, as per institutional guidelines and not yet treated pre-prostatectomy
• Subject is able to understand and willing to sign the participant information statement and consent form
• Subject is expected to remain available for 24 months of clinic visits
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Past history any other type of cancer (except skin cancer).
• Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
• Proven bony metastatic disease, visceral metastases or lymph node metastases above the level of the aortic bifurcation
• Previous surgery in pelvis (e.g. bilateral hip replacement) that limit the extent of pelvic lymph node dissection
• Patients who refuse radical prostatectomy or pelvic lymph node dissection
• Patients who refuse to join the trial or are unable to consent
• Patients not being considered for further therapy
• Patient has absolute contra-indications to undergoing MRI scanning
• Patients who cannot lie still for at least 60 to 75 minutes or comply with imaging
• Subject has medical conditions that would limit study participation (per physician discretion)
• Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
• Subject has a limited life expectancy that would not allow completion of the 24 month visits
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We will recruit 120 patients. Considering that each patient has 6 packets (a lump of fat containing lymph nodes) on average, we will be comparing 720 packets in total. This number will give 90% power to detect a 10% or less discordance between final histology analysis and the combined imaging modalities consensus.
We will compare ‘packet concordance rate’ between histology and MR Lymphography using a MRA arterial map (that can be acquired at the MRL) to locate the position of the lymph node, the 68Ga PSMA PET SCAN plus a combined evaluation, and histology. We will calculate the CONCORDANCE rate for positive nodes in each packet with their corresponding region on imaging, both against each individual imaging modality and against a summed score from both imaging techniques. Sensitivity, specificity, negative predictive values (NPVs), and positive predictive values (PPVs) will be reported. The maximum likelihood estimates (MLEs) of PPV and NPV will be calculated from the MLEs of the sensitivity, specificity, and prevalence rate. Hierarchical modelling will be used to test for concordance between matched results from each packet.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2019
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Actual
30/07/2019
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Date of last participant enrolment
Anticipated
1/01/2022
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Actual
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Date of last data collection
Anticipated
1/01/2031
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Actual
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Sample size
Target
120
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
12656
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St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [2]
12657
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [3]
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The Wesley Hospital - Auchenflower
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Recruitment postcode(s) [1]
25078
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
25079
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4066 - Auchenflower
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Funding & Sponsors
Funding source category [1]
301376
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Charities/Societies/Foundations
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Name [1]
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Paul Ramsay Foundation
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Address [1]
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Paul Ramsay Foundation
Level 9, 154 Pacific Hwy
St Leonards NSW 2065
Australia
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Country [1]
301376
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Garvan Institute of Medical Research
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Address
384 Victoria St
DARLINGHURST NSW 2010
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
301044
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Address [1]
301044
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Country [1]
301044
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302114
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St Vincent's Hospital Sydney Human Research Ethics Committee
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Ethics committee address [1]
302114
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97-105 Boundary Street
Darlinghurst NSW 2010
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Ethics committee country [1]
302114
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Australia
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Date submitted for ethics approval [1]
302114
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12/11/2015
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Approval date [1]
302114
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12/01/2016
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Ethics approval number [1]
302114
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HREC/15/SVH/402
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Summary
Brief summary
The purpose of this study is to determine if new imaging technologies are a valid and accurate method of detecting lymph node metastases.
Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer.
Study details
All participants will have 2 specialised imaging scans (68Ga-PSMA PET and nano-MRL) prior to a prostatectomy and lymph node dissection.
It is hoped that this research will help determine if these two imaging tests are useful in providing accurate but non-invasive methods of diagnosing metastatic prostate cancer. Thus guiding better targeted treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Phillip Stricker
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Address
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St Vincent’s Hospital, Sydney
St Vincent’s Prostate Cancer Centre
Suite 1001, Lvl 10, St Vincent’s Clinic,
408 Victoria Street
Darlinghurst NSW 2010
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Country
89158
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Australia
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Phone
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+61,02,83826971
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Fax
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+61,02,83826972
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Thomas Cusick
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Address
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The Kinghorn Cancer Centre 370 Victoria Street, Darlinghurst NSW 2010
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Country
89159
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Australia
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Phone
89159
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+610293555795
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Fax
89159
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Email
89159
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[email protected]
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Contact person for scientific queries
Name
89160
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Prof Phillip Stricker
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Address
89160
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St Vincent’s Hospital, Sydney St Vincent’s Prostate Cancer Centre Suite 1001, Lvl 10, St Vincent’s Clinic, 408 Victoria Street Darlinghurst NSW 2010
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Country
89160
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Australia
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Phone
89160
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+610283826971
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Fax
89160
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Email
89160
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual participant data will be de-identified and pooled to ensure anonymity of participants.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
615
Ethical approval
[email protected]
376525-(Uploaded-05-12-2018-12-15-38)-Study-related document.pdf
616
Study protocol
[email protected]
376525-(Uploaded-17-01-2020-10-46-41)-Study-related document.pdf
6628
Informed consent form
[email protected]
376525-(Uploaded-17-01-2020-11-02-24)-Study-related document.pdf
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.
Download to PDF