Imaging of Prostate Cancer Tumours Using 177Lu-NTA-476
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
GenesisCare
10 participants
Nov 3, 2025
Interventional
Conditions
Summary
This research project is testing whether NTA-476, labelled with a radioisotope called Lutetium-177 (177Lu) can be safely given to patients with prostate cancer and to find out where it goes in the body once it is injected into a person. NTA-476 labelled with Lutetium-177 is called Lu-NTA-476. Who is it for? You may be eligible for this study if you are a prostate cancer patient at GenesisCare Murdoch in Australia. Study details Participants will receive a single intravenous injection of 177Lu-NTA-476 and then undergo 3 single-photo emission computed tomography (SPECT)/CT scans at 2-4 hours, 20-28 hours and 72-96 hours after the injection of 177Lu-NTA-476. These scans will be compared to the standard of care prostate specific membrane antigen (PSMA) PET/CT scans used for diagnosing prostate cancer. It is hoped that findings from this study will assist researchers with developing novel, more accurate modalities of imaging for the diagnosis and staging of prostate cancer which could be used for treatment of future prostate cancer patients.
Eligibility
Inclusion Criteria6
- Adult participants aged 18 years and over
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
- Participants must have a life expectancy of more than 3 months in the opinion of the Investigator.
Exclusion Criteria4
- 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.
- 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)
- 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.
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Interventions
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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12625001028493