None listed
Conditions
Brief summary
This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer cells within the prostate and other tissues. Who is it for? You may be eligible for this study if you are a male aged 18 years or older and you have been diagnosed with prostate cancer that is metastatic and castration resistant (has not responded to surgical removal). Study details Participants who choose to enrol in this study will receive a single administration of 68Ga-NTA-14 (into a vein) 1 hour prior to Positron Emission Tomography (PET)/Computed Tomography (CT) imaging on Day 1. Between Day 3-8, a single administration of 68Ga-PSMA I&T will be administered (into a vein) 1 hour prior to PET imaging. PET/CT scans will be performed at 1 hour and 3 hours after administration of NTA-14 imaging agent and 1 hour after 68Ga-PSMA imaging agent. Participants will undergo safety monitoring which will include assessment of any side effects at 4 hours after administration of 68Ga-NTA-14. Participation will require up to 8 days including screening (Day -30 to 0), imaging with 68Ga-NTA-14 (Day 1), and imaging with 68Ga-PSMA I&T (Day 3-8). Participants will be followed up 1 hr post 68Ga-NTA-14 administration for evaluation of side effects. It is hoped this research will demonstrate that 68Ga-NTA-14 can be administered to patients without serious side effects, and that the images produced by this agent will be similar to or of better able to detect metastatic castration resistant prostate cancer cells compared to 68Ga-PSMA I&T images.
Interventions
NTA-14 is a peptidomimetic that binds to prostate-specific membrane antigen (PSMA), which is a transmembrane protein expressed at low levels in normal prostate tissue and in other organs and tissues, but its expression is markedly increased on prostate cancer cells.
This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer (mCRPC). Participants will undergo PET/CT imaging with 68Ga-NTA-14
NTA-14 is a peptidomimetic that binds to prostate-specific membrane antigen (PSMA), which is a transmembrane protein expressed at low levels in normal prostate tissue and in other organs and tissues, but its expression is markedly increased on prostate cancer cells. This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer (mCRPC). Participants will undergo PET/CT imaging with 68Ga-NTA-14. Participants will receive a single administration of 68Ga-NTA-14 via intravenous infusion by a radiation nurse/specialist prior to PET/CT imaging on Day 1. PET/CT scans will be performed at 1 hour and 3 hours after administration of each imaging agent. 68Ga-NTA-14 will be injected at a dose of 200 MBq.
Sponsors
St. Vincent's Hospital Sydney Limited
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Male, aged 18 years or older • Histologically confirmed diagnosis of prostate cancer that is metastatic and castration resistant • Rising PSA (greater than or equal to 2 ng/dL over nadir) following curative intent therapy (surgery) or radiographic disease progression by traditional imaging (CT/MRI/bone scan) • Signed, written informed consent • Completed or undergoing treatment for mCRPC and are being considered for clinical 177Lu-PSMA I&T treatment. • Participants must have adequate renal function: Creatinine clearance or estimated glomerular filtration rate greater than or equal to 35 mL/min/1.73 m2 .
Exclusion criteria
• Participants who cannot lie still for at least 30 minutes or comply with imaging procedures and study requirements. • Participants who are not suitable for 177Lu-PSMA I&T treatment based on investigator discretion.
Outcome results
None listed