UPCC 08821 Evaluating in vivo PARP-1 expression with 18F-FluorThanatrace positron emission tomography (PET/CT) in Patients with Metastatic Prostate Cancer
Studying PARP-1 in Advanced Prostate Cancer with PET/CT Scans
Brief description of study
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 of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate Cancer Metastatic
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Age: 18 years or above
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Gender: Male
Inclusion Criteria:
- Participants will be ≥ 18 years of age
- Histologically proven prostate carcinoma
- Clinical evidence of metastatic disease with at least one lesion identified on standard of care imaging (CT, MRI, Bone Scan, FDG or other PET/CT, Ultrasound)
- Considered a candidate for new therapy or change in therapy with PARP inhibitor therapy and/or androgen deprivation therapy (ADT) and/or chemotherapy with or without additional agents, either on a clinical trial or as part of clinical care.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria:
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
This study investigates PARP-1 expression in men with metastatic prostate cancer using a special imaging technique called PET/CT scans. The purpose of this study is to observe how a radiotracer, which is a substance used to highlight areas of the body in imaging tests, interacts with cancerous sites in the body. This study involves patients who are about to start a new treatment regimen for their cancer.
Participants in the study will undergo a PET/CT scan before starting their new therapy to measure the activity of PARP-1, a protein that can be involved in cancer progression. Some patients may also have a second optional scan after starting treatment to see if the therapy affects PARP-1 activity. The study is observational, meaning that it will not influence the treatment decisions made by doctors.
- Who can participate: Men aged 18 and older with a confirmed diagnosis of prostate cancer that has spread to other parts of the body can participate. Participants must be preparing to start or change their treatment plan, which may include a PARP inhibitor, androgen deprivation therapy, or chemotherapy.
- Study details: Participants will have a PET/CT scan to measure PARP-1 activity before starting new treatment. An optional second scan may be done after treatment begins to observe any changes. The study does not influence treatment decisions.
- Study visits: The study requires up to 2 visits.
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