NCT05242744

FTT PET/CT in Metastatic Prostate Cancer

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Metastatic Prostate Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

Summary

Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET/CT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.

Detailed description

Up to 30 evaluable patients with a histological diagnosis of prostate cancer with clinical evidence of metastatic disease who are being considered for new therapy or for a change in therapy with a PARP inhibitor, androgen deprivation therapy, and/or chemotherapy as part of their clinical care will be enrolled in this study. A pre-treatment 18F-FluorThanatrace (\[18F\]FTT) positron emission tomography/ computed tomography (PET/CT) scan will be done prior to the start of a new therapy regimen. PET/CT imaging will be used to evaluate PARP-1 expression in sites of prostate cancer using the investigational radiotracer \[18F\]FTT. This is an observational study in that \[18F\]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[18F\]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria. After injection of \[18F\]FTT patients will undergo a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of 12 mCi of \[18F\]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi ). of \[18F\] FTT. Data will be collected to evaluate uptake of \[18F\]FTT in sites of prostate cancer, which will be compared with PARP-1 expression in tissue, when available. All evaluable patients may start new therapy following the \[18F\]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 80% will also undergo a second (optional) scan that will be performed approximately 1-21 days after new therapy has started. The second scan is obtained to evaluate whether the initiation of a PARP inhibitor and/or androgen deprivation therapy and/or chemotherapy alters \[18F\] FTT uptake.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	[18F]FluorThanatrace	Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2022-02-16
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study