Imaging of Metastatic Prostate Cancer Tumors Using 68Ga-NTA-14

Not Applicable

Recruiting

• Conditions: Metastatic Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12621001704886
• Lead Sponsor: St. Vincent's Hospital Sydney Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-13
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the tumor uptake of 68Ga-NTA-14 as compared to<br>68Ga-PSMA I&T in participants with mCRPC using SUVmax, SUVmean and<br>total tumor volume by PET/CT quantitation.<br>[3 hours post-imaging];To characterize the uptake and wash out of 68Ga-NTA-14 as<br>compared to 68Ga-PSMA I&T in normal organs (eg salivary glands, kidneys, duodenum)[3 hours post-imaging]

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of 68Ga-NTA-14 by incidence of adverse events<br><br>[Due to intravenous infusion, local site irritation, bleeding or infection could be experienced. Radiation exposure is minimum for patients. <br>adverse effects to be assessed 4 hours post-imaging clinically as per patient reported on study data collection forms.];To evaluate the dosimetry of 68Ga-NTA-14[3 hours post-imaging from study records as per standard SOP guidelines. ]