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
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
Trial website
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.