68Ga-NTA-476 Imaging in Prostate Cancer
- Conditions
- Prostate CancerCancer - Prostate
- Registration Number
- ACTRN12623001157662
- Lead Sponsor
- GenesisCare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 10
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 at least 18 years of age.
3.Participants with a documented history of histologically confirmed diagnosis of prostate cancer.
oParticipants must have PSA more than 0.1ng/mL.
oParticipants 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.
oParticipants 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 equal to or less than 2
5.Participants must have a life expectancy of more than 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.
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 greater than Grade 1 from prior anti-cancer therapy (except alopecia). Participants with greater than 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:
oCreatinine clearance (calculated using Cockcroft-Gault formula, or measured) less than 60 mL/min or serum creatinine greater than 1.5 x upper limit of normal (ULN)
oPlatelet count of less than 75 x 10^9/L
oAbsolute neutrophil count (ANC) less than 1.0 x 10^9/L
oHaemoglobin less than 9 g/dL
oAlanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 x ULN, or more than 5 x ULN for patients with known liver metastases
oTotal bilirubin more than 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin equal to or less than 3 x ULN
11.For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) equal to or more than 1.5 or prothrombin time (PT) equal to or more than 1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) equal to or more than 1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR less than 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumour uptake of 68Ga-NTA-476 as compared to 68Ga-PSMA-11 in participants with prostate cancer [Standardised Uptake Value (SUV)max, SUVmean and total tumour volume by PET/CT quantitation PET/CT scans completed at 60 minutes and 2-3 hours following 68Ga-NTA-476 administration];Uptake and washout of 68Ga-NTA-476 in normal organs as compared to 68Ga-PSMA-11 in participants with prostate cancer. This will be assessed as a composite outcome.[Time Activity Curves (TACs), describing % of the injected activity vs time will be derived for selected organs and tumours including liver, kidneys and salivary glands. PET/CT scans completed at 60 minutes and 2-3 hours following 68Ga-NTA-476 administration]
- Secondary Outcome Measures
Name Time Method 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 Safety will be assessed on the Imaging Day in the clinic during observation for up to 4 hours post injection of 68Ga-NTA-476 and followed up for a total of 1 week following administration. ];Dosimetry of 68Ga-NTA-476[Absorbed radiation doses of 68Ga-NTA-476 in critical organs (e.g., kidneys, bone marrow) PET/CT scans completed at 60 minutes and 2-3 hours following 68Ga-NTA-476 administration]