Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001704886
Ethics application status
Approved
Date submitted
8/11/2021
Date registered
13/12/2021
Date last updated
13/12/2021
Date data sharing statement initially provided
13/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Imaging of Metastatic Prostate Cancer Tumors Using 68Ga-NTA-14
Scientific title
Imaging of Metastatic Prostate Cancer Tumors Using 68Ga-NTA-14
Secondary ID [1] 305739 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NTA-14
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 324232 0
Condition category
Condition code
Cancer 321717 321717 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NTA-14 is a peptidomimetic that binds to prostate-specific membrane antigen (PSMA), which is a transmembrane protein expressed at low levels in normal prostate tissue and in other organs and tissues, but its expression is markedly increased on prostate cancer cells.
This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer (mCRPC). Participants will undergo PET/CT imaging with 68Ga-NTA-14.
Participants will receive a single administration of 68Ga-NTA-14 via intravenous infusion by a radiation nurse/specialist prior to PET/CT imaging on Day 1. PET/CT scans will be performed at 1 hour and 3 hours after administration of each imaging agent. 68Ga-NTA-14 will be injected at a dose of 200 MBq.

Intervention code [1] 322136 0
Diagnosis / Prognosis
Comparator / control treatment
This study utilizes the PSMA binding small molecule PSMA I&T which has an identical PSMA binding moiety as PSMA-617 and a well characterized biodistribution profile. 68Ga-PSMAI&T is a small molecule that also binds PSMA and for which the normal tissue and tumor binding have been well described.
After 68Ga-NTA-14 scans conducted at day 1, patient is required to come back between Day 3-8, a single administration of 68Ga-PSMA I&T will be administered via intravenous infusion by a radiation nurse/specialist prior to PET imaging. PET/CT scan will be performed one time 1 hour post administration of the agent.
68Ga-PSMA I&T will be injected at a dose of 200 MBq.
Control group
Active

Outcomes
Primary outcome [1] 329476 0
To characterize the tumor uptake of 68Ga-NTA-14 as compared to
68Ga-PSMA I&T in participants with mCRPC using SUVmax, SUVmean and
total tumor volume by PET/CT quantitation.
Timepoint [1] 329476 0
3 hours post-imaging
Primary outcome [2] 329719 0
To characterize the uptake and wash out of 68Ga-NTA-14 as
compared to 68Ga-PSMA I&T in normal organs (eg salivary glands, kidneys, duodenum)
Timepoint [2] 329719 0
3 hours post-imaging
Secondary outcome [1] 402749 0
To evaluate the safety of 68Ga-NTA-14 by incidence of adverse events
Timepoint [1] 402749 0
Due to intravenous infusion, local site irritation, bleeding or infection could be experienced. Radiation exposure is minimum for patients.
adverse effects to be assessed 4 hours post-imaging clinically as per patient reported on study data collection forms.
Secondary outcome [2] 403584 0
To evaluate the dosimetry of 68Ga-NTA-14
Timepoint [2] 403584 0
3 hours post-imaging from study records as per standard SOP guidelines.

Eligibility
Key inclusion criteria
• Male, aged 18 years or older
• Histologically confirmed diagnosis of prostate cancer that is metastatic and castration resistant
• Rising PSA (greater than or equal to 2 ng/dL over nadir) following curative intent therapy (surgery) or radiographic disease progression by traditional imaging (CT/MRI/bone scan)
• Signed, written informed consent
• Completed or undergoing treatment for mCRPC and are being considered for clinical 177Lu-PSMA I&T treatment.
• Participants must have adequate renal function: Creatinine clearance or estimated glomerular filtration rate greater than or equal to 35 mL/min/1.73 m2 .
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants who cannot lie still for at least 30 minutes or comply with imaging procedures and study requirements.
• Participants who are not suitable for 177Lu-PSMA I&T treatment based on investigator discretion.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No prospective statistical analyses are proposed.
This is an exploratory study which will initially assess 68Ga-NTA-14 uptake in tumor and normal tissues, with the goal of determining if additional clinical development of NTA-14 is warranted. Retrospective statistical analyses of uptake with 68Ga-NTA-14, or a comparison of uptake between 68Ga-NTA-14 and 68Ga-PSMA I&T, may be performed if the dataset is large enough to support a meaningful evaluation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/11/2021
Date of last participant enrolment
Anticipated
29/11/2022
Actual
Date of last data collection
Anticipated
7/12/2022
Actual
Sample size
Target
10
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21046 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 35887 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 35888 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 310096 0
Commercial sector/Industry
Name [1] 310096 0
CLOVIS ONCOLOGY, INC
Country [1] 310096 0
United States of America
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Sydney Limited
Address
370 Victoria street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 311161 0
None
Name [1] 311161 0
Address [1] 311161 0
Country [1] 311161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309787 0
Bellberry Limited
Ethics committee address [1] 309787 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 309787 0
Australia
Date submitted for ethics approval [1] 309787 0
09/08/2021
Approval date [1] 309787 0
21/09/2021
Ethics approval number [1] 309787 0
2021/ETH11177

Summary
Brief summary
This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer cells within the prostate and other tissues.

Who is it for?
You may be eligible for this study if you are a male aged 18 years or older and you have been diagnosed with prostate cancer that is metastatic and castration resistant (has not responded to surgical removal).

Study details
Participants who choose to enrol in this study will receive a single administration of 68Ga-NTA-14 (into a vein) 1 hour prior to Positron Emission Tomography (PET)/Computed Tomography (CT) imaging on Day 1. Between Day 3-8, a single administration of 68Ga-PSMA I&T will be administered (into a vein) 1 hour prior to PET imaging. PET/CT scans will be performed at 1 hour and 3 hours after administration of NTA-14 imaging agent and 1 hour after 68Ga-PSMA imaging agent. Participants will undergo safety monitoring which will include assessment of any side effects at 4 hours after administration of 68Ga-NTA-14.

Participation will require up to 8 days including screening (Day -30 to 0), imaging with 68Ga-NTA-14 (Day 1), and imaging with 68Ga-PSMA I&T (Day 3-8).
Participants will be followed up 1 hr post 68Ga-NTA-14 administration for evaluation of side effects.

It is hoped this research will demonstrate that 68Ga-NTA-14 can be administered to patients without serious side effects, and that the images produced by this agent will be similar to or of better able to detect metastatic castration resistant prostate cancer cells compared to 68Ga-PSMA I&T images.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115386 0
Prof Louise Emmett
Address 115386 0
St. Vincent's Hospital
370 Victoria Street
Darlinghurst NSW 2010
Country 115386 0
Australia
Phone 115386 0
+61 2 83822621
Fax 115386 0
Email 115386 0
[email protected]
Contact person for public queries
Name 115387 0
Shikha Agrawal
Address 115387 0
St. Vincent's Hospital
370 Victoria Street
Darlinghurst NSW 2010
Country 115387 0
Australia
Phone 115387 0
+61 402901143
Fax 115387 0
Email 115387 0
[email protected]
Contact person for scientific queries
Name 115388 0
Louise Emmett
Address 115388 0
St. Vincent's Hospital
370 Victoria Street
Darlinghurst NSW 2010
Country 115388 0
Australia
Phone 115388 0
+61 2 83822621
Fax 115388 0
Email 115388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate data will be published in publications


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.