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Trial registered on ANZCTR


Registration number
ACTRN12624000935538p
Ethics application status
Submitted, not yet approved
Date submitted
22/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
68Ga-NTA-476 Imaging in Men with Prostate Cancer
Scientific title
A Single-Arm Comparative Imaging study to evaluate the uptake of 68Ga-NTA-476 on PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT in Men with Prostate Cancer
Secondary ID [1] 312504 0
None
Universal Trial Number (UTN)
U1111-1310-4819
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 334362 0
Condition category
Condition code
Cancer 331009 331009 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The novel Prostate Specific Membrane Antigen (PSMA) targeting molecule, NTA-476, is comprised of a small peptide targeting moiety that is attached to a linker and dodecane tetraacetic acid (DOTA) cage which enables chelation of the radionuclide 68Ga for Positron Emission Tomography (PET) imaging.

A single dose of 68Ga-NTA-476 will be administered on Day 1 of the study as an intravenous bolus injection under the supervision of the study Investigator or appropriately qualified delegate. The planned injected activity (IA) of 68Ga-NTA-476 is 2-3.5 MBq/kg.

Following administration of 68Ga-NTA-476, participants will complete PET imaging at 0-30 minutes, 1 hour, and 4-6 hours. Each PET scan will take up to 30 minutes.

As there is only a single intravenous injection of 68Ga-NTA-476 administered in this study, there are no strategies required to monitor adherence.
Intervention code [1] 329022 0
Diagnosis / Prognosis
Comparator / control treatment
68Ga-NTA-476 will be compared to 18F-DCFPyL imaging. Standard of care 18F-DCFPyL imaging will be obtained prior to participation in the trial as part of standard clinical care or during the screening period if not completed within the past 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 338771 0
Tumour uptake of 68Ga-NTA-476 as compared to 15F-DCFPyl in participants with prostate cancer
Timepoint [1] 338771 0
PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Primary outcome [2] 338772 0
To characterize the uptake and washout of 68Ga-NTA-476 in normal organs as compared to 18F-DCFPyL in participants with prostate cancer. These will be assessed as a composite outcome.
Timepoint [2] 338772 0
PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Secondary outcome [1] 437392 0
To assess the safety and tolerability of a single dose of 68Ga-NTA-476
Timepoint [1] 437392 0
Safety will be assessed on the Imaging Day in the clinic during observation for up to 6 hours post injection of 68Ga-NTA-476 and followed up for a total of 1 week following administration.
Secondary outcome [2] 437393 0
To explore the dosimetry of 68Ga-NTA-476
Timepoint [2] 437393 0
PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration

Eligibility
Key inclusion criteria
1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
2. Adult participants greater than or equal to 18 years of age.
3. Participants with a documented history of histologically confirmed diagnosis of prostate cancer.
o Participants must have PSA > 0.1 ng/mL.
o Participants on chemotherapy may be approved on a case-by-case basis at the principal investigator's discretion if the last dose of chemotherapy is administered at least 3 weeks prior to receipt of 68Ga-NTA-476, and subsequent dose of chemotherapy are to resume following completion of End of Treatment Visit (EOTV), if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
o Participants on other anti-cancer therapy, such as novel anti-androgen therapy, may be allowed on a case-by-case basis at the principal investigator's discretion, with an agreement of a washout period prior to 68Ga-NTA-476 dosing, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
5. Participants must have a life expectancy of >3 months in the opinion of the Investigator.
6. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 68Ga-NTA-476. Participants must agree to not donate sperm during the study and for 14 days after the injection of 68Ga-NTA-476. Acceptable methods of contraception include a condom in conjunction with hormonal contraception, a vaginal ring or intrauterine device (IUD), or documented evidence of surgical sterilisation. Confirmed absence of sperm in the ejaculate is also acceptable.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
7. Have any medical condition that would, in the Investigator’s judgment, prevent the participant’s full participation in the clinical study due to safety concerns or compliance with clinical study procedures, including but not limited to participants with severe claustrophobia.
8. Residual toxicity > Grade 1 from prior/current anti-cancer therapy (except alopecia). Participants with > Grade 1 toxicity from prior anti-cancer therapy may be approved on a case-by-case basis at the principal investigator's discretion, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
9. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-NTA-476 or any of its excipients.
10. Inadequate organ functions as reflected in laboratory parameters:
o Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x upper limit of normal (ULN)
o Platelet count of < 75 x 109/L
o Absolute neutrophil count (ANC) < 1.0 x 109/L
o Haemoglobin < 9 g/dL
o Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases
o Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin is less than or equal to 3 x ULN
11. For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) less than or equal to 1.5 or prothrombin time (PT) less than or equal to 1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) less than or equal to 1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR <3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.
12. Major surgery within 28 days prior to the dose of 68Ga-NTA-476. Exceptions may be approved on a case-by-case basis at the principal investigator's discretion, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
13. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.

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 0
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/08/2024
Actual
Date of last participant enrolment
Anticipated
14/11/2024
Actual
Date of last data collection
Anticipated
28/11/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316926 0
Commercial sector/Industry
Name [1] 316926 0
3B Pharmaceuticals
Country [1] 316926 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Melbourne Theranostic Innovation Centre
Address
Country
Australia
Secondary sponsor category [1] 319170 0
None
Name [1] 319170 0
Address [1] 319170 0
Country [1] 319170 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315679 0
Bellberry Human Research Ethics Committee E
Ethics committee address [1] 315679 0
https://bellberry.com.au/
Ethics committee country [1] 315679 0
Australia
Date submitted for ethics approval [1] 315679 0
17/07/2024
Approval date [1] 315679 0
Ethics approval number [1] 315679 0

Summary
Brief summary
This study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 18F-DCFPyl. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans.

It is hoped that this compound will provide more accurate PET imaging with less non-specific activity to enhance diagnostic and therapeutic outcomes.

Who is it for?
You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with prostate cancer and do not have any significant other health issues.

Study details
All participants who choose to participate will complete a Screening Visit to make sure that they meet the eligibility requirements for the study. Procedures completed during this visit will include demographic details, medical history, physical examination, vital signs, ECG, blood samples to check overall health status and a 18F-DCFPyl PET scan.

Following confirmation of eligibility, participants will complete an Imaging Day Visit. During this visit, single dose of 68Ga-NTA-476 will be injected via a vein into the body. Following this, PET scans will be completed at about 0-30 minutes, 1 hour, and 4-6 hours. Participants will be observed in the clinical for a total of 6 hours to check vital signs and record any side effects.

Between 7-9 days after this, a final study visit will be completed. Blood samples will be collected to check overall health status and the research team will check to see if any side effects were experienced.

A total of 10 participants will be enrolled in this study at Melbourne Theranostic Innovation Centre in Australia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135482 0
Prof Rodney Hicks
Address 135482 0
Melbourne Theranostic Innovation Centre. Level 8, 14-20 Blackwood St. North Melbourne 3051
Country 135482 0
Australia
Phone 135482 0
+61 03 9454 5800
Fax 135482 0
Email 135482 0
[email protected]
Contact person for public queries
Name 135483 0
Christopher Marinakis
Address 135483 0
Melbourne Theranostic Innovation Centre. Level 8, 14-20 Blackwood St. North Melbourne 3051
Country 135483 0
Australia
Phone 135483 0
+61 03 9454 5808
Fax 135483 0
Email 135483 0
[email protected]
Contact person for scientific queries
Name 135484 0
Jason Callahan
Address 135484 0
Melbourne Theranostic Innovation Centre. Level 8, 14-20 Blackwood St. North Melbourne 3051
Country 135484 0
Australia
Phone 135484 0
+61 03 9454 5800
Fax 135484 0
Email 135484 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
PICF does not allow for sharing of IPD


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.