Pilot Study – Role of Fibroblast Activation Protein Inhibitor Positron Emission Tomography (FAPI PET) in patients with metastatic castrate resistant prostate cancer.

Not Applicable

• Conditions: Metastatic Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12623000135617
• Lead Sponsor: Mercy Radiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

Patient age >= 18 years.
•All patients diagnosed with Castrate Resistant Prostate Cancer referred for 177Lu-PSMA therapy, undergoing or having undergone assessment for discordant disease within 3 months from baseline
•Able to give informed consent
•Willing to use effective contraceptive methods for the duration of the study

Exclusion Criteria

Pts with confirmed disease who have not had [18F]FDG PET CT and 68Ga-PSMA
•Patients unable, or unwilling to consent
•Unwilling to use contraceptive methods

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients’ scans will be assessed following completion of FDG PET, 68Ga-PSMA PET and FAPI PET. Patients not progressing to all three scans following consent to participate will be recorded.<br>[Primary endpoint will be achieved at the end of the study as cumulative data is essential to assess outcome];Feasibility of a larger multicenter trial. This will include: Patient screening rate (number of screened over time); enrolment rate (number of enrolled over time); screening failure (total number of enrolled/total number of screened); reasons for screening failure, retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion.<br>Data will be obtained through recruitment logs and patient study records[Primary endpoint will be achieved at the end of the study as cumulative data is essential to assess outcome]

Secondary Outcome Measures

Name	Time	Method
umber of patients with uptake at [68Ga]Ga-FAPI PET/CT deemed diagnostic by study criteria This information will help determine if [68Ga]Ga-FAPI could be a more effective agent in detecting the extent of disease and discordant disease[24 hours post FAPI PETCT]