Prostate CancerEarly Phase 1NTA-476NCT06520449
68Ga-NTA-476 Imaging in Prostate Cancer
A Early Phase 1 study testing 68Ga-NTA-476 in people with Prostate Cancer, run by Melbourne Theranostic Innovation Centre at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-NTA-476
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Sep 2024to 17 Jan 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Adult participants = 18 years of age.
- Participants with a documented history of histologically confirmed diagnosis of prostate cancer.
- Participants must have PSA > 0.1 ng/mL.
- 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.
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- Participants must have a life expectancy of >3 months in the opinion of the Investigator.
- 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 are described in section 14.3.1 of the Protocol.
Who cannot join
- 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.
- 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.
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-NTA-476 or any of its excipients.
- Inadequate organ functions as reflected in laboratory parameters:
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x upper limit of normal (ULN)
- Platelet count of < 75 x 109/L
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- Absolute neutrophil count (ANC) < 1.0 x 109/L
- Haemoglobin < 9 g/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases
- Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin = 3 x ULN
- For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) =1.5 or prothrombin time (PT) =1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) =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.
- 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.
- Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Melbourne Theranostic Innovation Centre
Melbourne, Victoria, 3051
About this study
Official title: A Single-Arm Comparative Imaging Study of 68Ga-NTA-476 PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT in Men With Prostate Cancer
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.
Read the detailed description
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.
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
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-NTA-476
- Keywords
- prostate cancer, PET/CT, PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NTA-476Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NTA-476 PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT | Experimental | 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. Receives: Drug: 68Ga-NTA-476 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour uptake of 68Ga-NTA-476 as compared to 15F-DCFPyl in participants with prostate cancer
Standardised Uptake Value (SUV)max, SUVmean and total tumour volume by PET/CT quantitation
Measured: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
To characterize the uptake and washout of 68Ga-NTA-476 in normal organs as compared to 18F-DCFPyL in participants with prostate cancer
Time Activity Curves (TACs), describing % of the injected activity vs time will be derived for selected organs and tumours
Measured: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Secondary outcomes (2)
To assess the safety and tolerability of a single dose of 68Ga-NTA-476
Safety is evaluated with the properties, incidence, nature and severity of AEs and SAEs, abnormal laboratory parameters, vital signs, and electrocardiogram (ECG) results per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 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.
To explore the dosimetry of 68Ga-NTA-476
Absorbed radiation doses of 68Ga-NTA-476 in critical organs (e.g., kidneys, bone marrow)
Measured: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start13 Sep 2024
- Primary completion12 Dec 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Theranostic Innovation Centre
- Sponsor type
- Research network
- Collaborators
- 3B Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Prof.Rod Hicks, MB BS, MD, FRACP, FICIS, Principal investigator, Melbourne Theranostic Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520449
- Sponsor's protocol ID
- 2024-07-851
- Acronym
- NTA-476
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PICF does not allow for sharing of IPD
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Comparative Imaging Study of 68Ga-NTA-476 PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06520449
- Acronym / sponsor ID
- NTA-476 / 2024-07-851
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, PET/CT, PSMA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Melbourne Theranostic Innovation CentreResearch network
- Collaborators
- 3B Pharmaceuticals GmbH
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NTA-476 PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT | Experimental | Drug: 68Ga-NTA-476A 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Adult participants = 18 years of age.
- Participants with a documented history of histologically confirmed diagnosis of prostate cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- Participants must have a life expectancy of >3 months in the opinion of the Investigator.
Key exclusion criteria (13 listed)
- 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.
- 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.
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-NTA-476 or any of its excipients.
- Inadequate organ functions as reflected in laboratory parameters:
- For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) =1.5 or prothrombin time (PT) =1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) =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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NTA-476The 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. | Drug | 68Ga-NTA-476 PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT |
Primary outcome
Tumour uptake of 68Ga-NTA-476 as compared to 15F-DCFPyl in participants with prostate cancer
Time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Standardised Uptake Value (SUV)max, SUVmean and total tumour volume by PET/CT quantitation
To characterize the uptake and washout of 68Ga-NTA-476 in normal organs as compared to 18F-DCFPyL in participants with prostate cancer
Time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Time Activity Curves (TACs), describing % of the injected activity vs time will be derived for selected organs and tumours
2 secondary outcomes
To assess the safety and tolerability of a single dose of 68Ga-NTA-476
Time frame: 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.
To explore the dosimetry of 68Ga-NTA-476
Time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. PICF does not allow for sharing of IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof.Rod Hicks, MB BS, MD, FRACP, FICIS principal investigator
Melbourne Theranostic Innovation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-NTA-476 in people with Prostate Cancer, run by Melbourne Theranostic Innovation Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour uptake of 68Ga-NTA-476 as compared to 15F-DCFPyl in participants with prostate cancer (time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.