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This information is intended for US healthcare professionals (HCPs).

Understanding prostate cancer

Quick Facts

Icon of 8 stick figures where 1 is orange and 7 are black

Prostate cancer is a leading cause of new cancer cases in men, affecting 1 in 8 American men.

Approximately

288,300

new cases of prostate cancer are expected to be diagnosed in the United States in 2023.

Quick Facts

Prostate cancer is the

2nd leading cause

of cancer-related death in men in the United States, but survival rates are improving as detection and treatment technology continues to advance.

Early detection

Plus

Treatment

 

Plus

 

3.1
million

prostate cancer survivors in the United States.

Quick Facts

Icon of 8 stick figures where 1 is orange and 7 are black

Prostate cancer is a leading cause of new cancer cases in men, affecting 1 in 8 American men.

Approximately

288,300

new cases of prostate cancer are expected to be diagnosed in the United States in 2023.

Prostate cancer is the

2nd leading cause

of cancer-related death in men in the United States, but survival rates are improving as detection and treatment technology continues to advance.

Early
detection

Plus

Treatment

Plus

3.1
million

prostate cancer survivors
in the United States.

The information provided by a POSLUMA PET scan may help you and your doctor make more informed decisions about your treatment.

A Closer Look

    Screening for prostate cancer is a decision made between you and your doctor after considering various factors, such as your age, family history, and other medical conditions. While there isn’t one standard test for screening, prostate-specific antigen (PSA) testing is common.

    Information callout icon

    PSA is a substance made by the prostate that can be elevated in men with prostate cancer and detected in the blood

    If your doctor suspects prostate cancer, that’s when a biopsy may be scheduled.

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    A biopsy is a procedure to remove a piece of tissue or sample of cells from your body so that it can be tested in a laboratory and confirm whether or not you have prostate cancer

    Upon diagnosis, your doctor will take steps to develop a treatment plan that’s right for you.

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    Based on the information gathered on your disease, your treatment plan will detail the goals, expected length, and any other important considerations of the treatment selected by you and your doctor. Continue reading for more about how your doctor may gather information to help develop your treatment plan

    A man and his partner sitting in a doctors office having a conversation with his doctor

      Up to 40% to 50% of men diagnosed and treated for prostate cancer will have a recurrence within 10 years.

      Information callout icon

      Recurrent prostate cancer means that your disease has come back after treatment

      If you’ve been diagnosed with prostate cancer previously, one way your doctor monitors your health is with regular PSA testing. If your doctor suspects recurrence, an imaging scan may be necessary.

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      You can learn more about imaging scans in the next section

        It’s vital to know where prostate cancer is located in your body so that you and your doctor can choose the most appropriate treatment plan. Imaging scans are often used to help your doctor determine the location of the cancer and whether it has metastasized.

        Information callout icon

        Metastasized means that the cancer has spread to other parts of the body, including lymph nodes, bones, or other tissues

        Man receiving an imaging scan

        While multiple types of imaging scans can help provide important information about prostate cancer, they all have pros and cons.

          Common imaging scan overview
          Prostate cancer detection
          In bones In soft tissue When it’s
        very small
        When PSA
        levels are low
        PET Yes icon Yes icon Yes icon* Yes icon
        CT Yes icon Yes, with limitations icon Yes, with limitations icon No icon
        MRI Yes icon Yes, with limitations icon Yes, with limitations icon No icon
        Bone scan Yes icon N/A N/A No icon
        Prostate cancer detection
        PET
        Yes iconIn bones
        Yes iconIn soft tissue
        Yes icon*When it’s very small
        Yes iconWhen PSA levels are low
        CT
        Yes iconIn bones
        Yes, with limitations iconIn soft tissue
        Yes, with limitations iconWhen it’s very small
        No iconWhen PSA levels are low
        MRI
        Yes iconIn bones
        Yes, with limitations iconIn soft tissue
        Yes, with limitations iconWhen it’s very small
        No iconWhen PSA levels are low
        Bone scan
        Yes iconIn bones
        N/AIn soft tissue
        N/AWhen it’s very small
        No iconWhen PSA levels are low
          Yes icon = yes Yes, with limitations icon = yes, with limitations No icon = no N/A  = not applicable
        Yes icon = yes Yes, with limitations icon = yes, with limitations
        No icon = no N/A  = not applicable

        While PET scans have limitations in detecting microscopic metastases, they do detect smaller metastases than CT scans or MRIs.

        PSA <2 ng/mL.

        CT=computed tomography; MRI=magnetic resonance imaging;
        PET=positron emission tomography; PSA=prostate-specific antigen.

        Why PET scans matter

        Because it provides your doctor with important information, a PET scan is often chosen to help develop a more informed treatment plan for prostate cancer. POSLUMA is an imaging agent for PET scans.

        Understanding the information provided by different imaging scans can help you advocate for yourself, and talk to your doctor about which ones may be right for you.

        Indication

        POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

        • with suspected metastasis who are candidates for initial definitive therapy
        • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

        INDICATION | IMPORTANT SAFETY INFORMATION

        INDICATION

        POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

        • with suspected metastasis who are candidates for initial definitive therapy
        • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

        IMPORTANT SAFETY INFORMATION

        • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
        • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
        • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
        • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
        • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

        To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

        Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

        • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
        • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
        • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
        • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
        • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

        To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

        Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

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