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Fluciclovine F18 · 1 trial · 1 indication
A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.
| Arm | Type | Description |
|---|---|---|
| Arm I (fluciclovine F18, PET/CT) | EXPERIMENTAL | Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. |
| Arm II (68Ga-PSMA, PET/CT) | ACTIVE_COMPARATOR | Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| Computed Tomography | PROCEDURE | Undergo PET/CT |
| Fluciclovine F18 | DRUG | Given IV |
| Gallium Ga68-labeled PSMA-11 | RADIATION | Given IV |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
Inclusion Criteria: * Adenocarcinoma of the prostate, post radical-prostatectomy * Detectable prostate-specific antigen (PSA) * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2 * No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) o...
Fluciclovine F18 is an investigational small molecule being studied for use in prostate adenocarcinoma. It is a diagnostic imaging agent that is being evaluated in a Phase 2 clinical trial to enhance prostate cancer outcomes. The drug is not yet approved and remains in clinical development.
Fluciclovine F18 is a synthetic amino acid that is taken up by prostate cancer cells. It is used in positron emission tomography (PET) imaging to visualize prostate cancer. The drug targets amino acid transporters that are overexpressed in prostate cancer cells, allowing for detection of the disease.
Fluciclovine F18 is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with prostate adenocarcinoma.
Fluciclovine F18 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is active but not recruiting participants, and is designed to assess the drug's ability to enhance prostate cancer outcomes.
Fluciclovine F18 is being evaluated in a Phase 2 clinical trial with the identifier NCT03762759. The trial, titled 'Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes,' is enrolling 140 male patients aged 18 years and older with prostate adenocarcinoma in the United States. The study is active but not recruiting.
Fluciclovine F18 is not the same as Ga68-PSMA. Fluciclovine F18 is a synthetic amino acid used for PET imaging, while Ga68-PSMA is a different imaging agent that targets prostate-specific membrane antigen. The two agents are being compared in a clinical trial to determine which is more effective for enhancing prostate cancer outcomes.