Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001028493p
Ethics application status
Submitted, not yet approved
Date submitted
27/08/2025
Date registered
17/09/2025
Date last updated
17/09/2025
Date data sharing statement initially provided
17/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Imaging of Prostate Cancer Tumours Using 177Lu-NTA-476
Scientific title
A Phase 0, Single-centre, Open-label, Non-randomized Imaging Study to Investigate the Safety and Dosimetry of 177Lu-NTA-476 in Prostate Cancer Patients
Secondary ID [1] 315248 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 338703 0
Condition category
Condition code
Cancer 334988 334988 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-arm, single-centre, open-label, non-randomized imaging trial in men with prostate cancer. Participants will undergo prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging during the screening period. The PSMA-PET/CT imaging is performed as a standard of care. Once enrolled, participants will receive a single intravenous injection of 177Lu-NTA-476 (1-1.5GBq in 10ml syringe). This is drawn up individually for each patient - it is a manual process and the radioactivity differs as it is a dynamic process of radioisotope decay causing the variation in dose. That is why a range is provided. It is not an exact mg or ml measurement. The participant will then undergo three single-photon emission computed tomography (SPECT)/CT scans: at 2-4 h, 20-28 h, and 72-96 h after the injection of 177Lu-NTA-476. Participants will have to lie still with each scan for 30-45 minutes. The total time for the scan from start to finish is about 1.5-3 hours.

As there is only a single intravenous injection of 177Lu-NTA-476 administered in this study, there is no strategies required to monitor adherence.
Intervention code [1] 331856 0
Diagnosis / Prognosis
Comparator / control treatment
177Lu-NTA-476 will be compared to standard of care PSMA diagnostic tracers used for imaging prostate cancer. A PET/CT using a PSMA diagnostic tracer 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] 342619 0
To characterize the tumour uptake of 177Lu-NTA-476 and its washout over time.
Timepoint [1] 342619 0
3 single-photon emission computed tomography (SPECT)/CT scans: at 2-4 h, 20-28 h, and 72-96 h after the injection of 177Lu-NTA-476.
Primary outcome [2] 342620 0
To assess the safety and tolerability of a single dose of 177Lu-NTA-476.
Timepoint [2] 342620 0
Safety will be assessed on the Imaging Day in the clinic during observation for up to 2- 4 hours post injection of 177Lu-NTA-476 and followed up for a total of 14 days following administration. Follow-up of an adverse event is required until the event resolves or stabilises at a level acceptable to the investigator, even if the AE persists after the date of therapy discontinuation.
Secondary outcome [1] 451554 0
To characterize the uptake and washout of 177Lu-NTA-476 in normal organs.
Timepoint [1] 451554 0
(SPECT)/CT scans: at 2-4 h, 20-28 h, and 72-96 h after the injection of 177Lu-NTA-476.
Secondary outcome [2] 451555 0
To measure the radiation dosimetry of 177Lu-NTA-476
Timepoint [2] 451555 0
3 single-photon emission computed tomography (SPECT)/CT scans: at 2-4 h, 20-28 h, and 72-96 h after the injection of 177Lu-NTA-476.

Eligibility
Key inclusion criteria
1. Adult participants aged 18 years and over
2. At least one PSMA-positive lesion must be visible on PET/CT imaging following administration of a PSMA diagnostic tracer. A lesion is considered positive if its maximum standard uptake value (SUVmax) is equal to or greater than 10.
3. Participants with a documented history of histologically confirmed diagnosis of prostate cancer:
Participants currently receiving chemotherapy other anti-cancer therapy, such as such as novel anti-androgen therapy, may be approved on a case-by-case basis if, in the opinion of the principal investigator, such treatment is not likely to put the participant at increased risk of adverse drug effects and/or to interfere with the integrity of study outcome.
4. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
5. Participants must have a life expectancy of more than 3 months in the opinion of the Investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Residual toxicity greater than Grade 1 from prior or current anti-cancer therapy (except alopecia). Participants with greater than Grade 1 toxicity from prior or current 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 the study outcome.
2. Inadequate organ function as reflected in laboratory parameters:
? Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) less than 60 mL/min or serum creatinine greater than 1.5 times the upper limit of normal (ULN)
3. Major surgery within 28 days prior to the dose of 177Lu-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.

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
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
4/05/2026
Actual
Date of last data collection
Anticipated
18/05/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28389 0
GenesisCare - Murdoch - Murdoch
Recruitment postcode(s) [1] 44612 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 319814 0
Commercial sector/Industry
Name [1] 319814 0
3B Pharmaceuticals
Country [1] 319814 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
Country
Australia
Secondary sponsor category [1] 322331 0
None
Name [1] 322331 0
Address [1] 322331 0
Country [1] 322331 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318372 0
Bellberry Human Research Ethics Committee B
Ethics committee address [1] 318372 0
Ethics committee country [1] 318372 0
Australia
Date submitted for ethics approval [1] 318372 0
02/09/2025
Approval date [1] 318372 0
Ethics approval number [1] 318372 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143978 0
Dr Aviral Singh
Address 143978 0
GenesisCare, 100 Murdoch Drive, Murdoch WA 6150 (access via St John of God Murdoch Hospital, Gate 3
Country 143978 0
Australia
Phone 143978 0
+61 499583667
Fax 143978 0
Email 143978 0
[email protected]
Contact person for public queries
Name 143979 0
Rebecca Nathan
Address 143979 0
GenesisCare, Building 7C & D, Level 1, The Mill, 41-43 Bourke Road Alexandria NSW 2015
Country 143979 0
Australia
Phone 143979 0
+61 429777325
Fax 143979 0
Email 143979 0
[email protected]
Contact person for scientific queries
Name 143980 0
Rebecca Nathan
Address 143980 0
GenesisCare, Building 7C & D, Level 1, The Mill, 41-43 Bourke Road Alexandria NSW 2015
Country 143980 0
Australia
Phone 143980 0
+61 429777325
Fax 143980 0
Email 143980 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.