None listed
Conditions
Brief summary
Patients with patients with metastatic castrate resistant prostate cancer (MCRPC) referred for therapy with Lutetium, will undergo an assessment for discordant disease. This is usually done by asking patients to have 2 PETCT scans with different agents that we call tracers. The increased binding by the FDG tracer and absent or significantly reduced binding 68G- PSMA defines discordant disease. The finding of significant “discordant” disease may result in a recommendation not to proceed with therapy. Absent, or markedly reduced tumor binding of or 68Ga-PSMA, implies disease unlikely to respond to lutetium therapy. Other studies show moderate tumor binding of 68Ga-FAPI in patients with MCRPC. The aim of this study is to determine FAPI’s range and patterns of tumor binding in patients with discordant disease. If we can establish if FAPI has a greater range of tumor binding than other tracers used, this will lead to a simpler method of disease staging. More importantly this may lead to the possibility of using Lu177-FAPI as a therapy for patients with discordant disease.
Interventions
This Study is a Open label , non randomized prospective pilot.
We plan to conduct a prospective, observational, pilot study on 10 consecutively recruited patients with known metastatic prostate cancer, on the basis of current accepted diagnostic criteria.
Eligible patients will be referred by their Oncologist to our Pet CT department.
A member of the Research team will contact those patients to confirm eligibility and willingness to participate. Once patients have been recruited they will under
This Study is a Open label , non randomized prospective pilot. We plan to conduct a prospective, observational, pilot study on 10 consecutively recruited patients with known metastatic prostate cancer, on the basis of current accepted diagnostic criteria. Eligible patients will be referred by their Oncologist to our Pet CT department. A member of the Research team will contact those patients to confirm eligibility and willingness to participate. Once patients have been recruited they will undergo a PET CT scan using [68Ga]Ga-FAPI. Eligible patients would have undergone assessment for lutetium therapy as standard care. Part of this assessment will include 2 types of PETCTs: 68Ga- PSMA and FDG. Patients will be invited to the study must have undergone lutetium therapy suitability assessment no longer than 3 months prior to the FAPI PET. All study activity will be carried out at Mercy Radiology, Epsom branch. Patients will receive 1 dose of [68Ga]Ga-FAPI before their PET scan. Average radiation dose of 260MBq. The Agent will be administered intravenously under the supervision of the radiologist by a suitably trained member of staff. So far there is no known adverse effects of FAPI serious or otherwise The radiation exposure is considerably lower than imaging agents currently used Patients can expect a single visit to our PETCT department. The study visit will last approximately 2 hours
Sponsors
Mercy Radiology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed