Prostate cancer care

Guided By Illumination

Illuccix® can help your doctor get a more
precise picture of your prostate cancer

Illuccix is used to prepare an advanced imaging tracer that is designed to help your doctor detect the presence of cancer cells in your body. Illuccix is used with an imaging technique called a positron emission tomography (PET) scan.

A PET scan with Illuccix may detect tumors more accurately than conventional imaging and provide your care team with the information they need to determine the appropriate treatment plan for you.

If you have any questions, please reach out to your doctor or a member of your care team.

Accurate assessment of your disease is essential because it may affect your treatment plan.

Understanding newly diagnosed prostate cancer

Your doctor may have talked to you about the risk level of your prostate cancer. Risk level often ranges from low to intermediate to high. It’s based on PSA levels, size and location of the tumor, and how aggressive the tumor looks.

If prostate cancer comes back

While every patient is different, up to 40%-50% of patients’ prostate cancer will come back after the 10-year mark following treatment. Whether a patient’s cancer will come back is associated with their risk levels during their initial diagnosis and response to treatment. If prostate cancer stops responding to a treatment regimen, your doctor may assess whether you may be a candidate for other treatments, including PSMA-targeted radioligand therapy.

Scroll below to learn more about PSA and PSMA.

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Regular screenings and access to advanced imaging are crucial

5-year survival rates are nearly 100% when prostate cancer is detected early in and around the prostate region.

Consistent checkups, ongoing screening of PSA levels, and access to advanced imaging, such as a PET scan with Illuccix, are crucial for early detection and accurate diagnosis.

Why your doctor might recommend a PET scan with Illuccix

A PET scan with Illuccix may be recommended when your risk levels are relatively high after initial diagnosis or PSA levels are rising after treatment. This may help your doctor determine if the cancer has come back or spread to other parts of the body.

Illuccix can also help your doctor determine if treatments like PSMA-directed radioligand therapy would be appropriate for you.

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What rising PSA means

PSA, or prostate-specific antigen, is a protein produced by both healthy and cancerous cells of the prostate gland. PSA levels are useful as an early sign of prostate cancer or to indicate that prostate cancer has come back or spread.

However, PSA levels can go up or down for a variety of outside factors, such as particular forms of exercise, recent sexual activity, and certain medications. Because of this variability, more reliable screening tools may be necessary. That is why your doctor may order imaging tests.

The benefits of a PET scan with Illuccix

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Can give doctors greater clarity regarding the extent of your prostate cancer and determine your eligibility for PSMA-directed radioligand therapy

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A better understanding of your prostate cancer can help you and your doctors make more informed decisions about your treatment plan

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The Illuccix tracer can be prepared on demand, which can provide greater flexibility in scheduling an appointment

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The Illuccix tracer reduces to minimal levels after 6 hours

PSMA is a precise imaging target that can help detect prostate cancer

  • PSMA, which stands for prostate-specific membrane antigen, is a protein that is abundant on the surface of prostate cancer cells. This is what makes PSMA a good target for prostate cancer imaging
  • PSMA is also found on cancer cells that have spread to other parts of the body, like the lymph nodes or bones
  • PSMA imaging may be able to detect tumors that are undetectable with conventional imaging, which relies on size and shape of tumor

Illuccix binds to PSMA to illuminate prostate cancer

What’s important about Illuccix as a tracer is that it is able to attach to PSMA proteins on cancerous cells. During the PET scan, Illuccix lights up these proteins wherever they are in the body.

This advanced imaging tracer can help your care team make more informed decisions about your treatment path forward.

Detection of prostate cancer with PSMA scan in the body

How Illuccix is different from conventional imaging technology

Depending on your prostate cancer, your doctor may recommend different kinds of imaging, such as:

  • Computed tomography (CT): Uses x-rays to show size and shape of organs, and is often used to see if tumors have grown, spread, or returned
  • Magnetic resonance imaging (MRI): Uses radio waves and strong magnets to create images of soft tissue, including tumors
  • Bone scans: Uses an imaging tracer to locate cancer that has spread to the bones

A PET scan with Illuccix: Uses an imaging tracer to target the specific PSMA protein on cancer cells throughout the body. A PET scan with Illuccix may be able to detect cancer when PSA levels are low and when tumors are small or conventional imaging results are uncertain.

Leading cancer organizations recommend the use of a PET scan, including a PET scan with Illuccix, to detect prostate cancer after initial diagnosis and if the cancer comes back.

Safety Information

Illuccix uses a small amount of radioactive material that reduces to minimal levels after 6 hours. Then the product is eliminated from the body through the urine.

The safety of Illuccix was evaluated in 3 clinical studies:

  • In studies that included 960 men who were newly diagnosed with prostate cancer or whose cancer came back after initial treatment, the most common side effects that occurred in less than 1% of people were nausea, diarrhea, and dizziness
  • In another clinical study of 1003 men, where Illuccix PET scan was performed to assess eligibility for PSMA-directed radioligand therapy, the side effects that occurred in more than or equal to 0.5% of people were fatigue, nausea, constipation, and vomiting. Side effects that occurred at a rate of less than 0.5% were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth, and chills
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Indications and Usage

ILLUCCIX, after radiolabeling with GA 68, is a radioactive diagnostic agent 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
  • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Important Safety Information

Warnings and Precautions

Risk for Misinterpretation

Image interpretation errors can occur with ILLUCCIX 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. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Indications and Usage

ILLUCCIX, after radiolabeling with GA 68, is a radioactive diagnostic agent 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
  • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Important Safety Information

Warnings and Precautions

Risk for Misinterpretation

Image interpretation errors can occur with ILLUCCIX 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. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Imaging to Select Patients for Lutetium Lu 177 Vipivotide Tetraxetan Therapy

The interpretation of ILLUCCIX PET may differ depending on imaging readers. ILLUCCIX PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any one tumor lesion compared to judging uptake for all lesions larger than size criteria. Multidisciplinary consultation to select patients for lutetium Lu 177 vipivotide tetraxetan therapy is recommended, particularly for ILLUCCIX imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in clinical studies, each receiving one dose of gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In a clinical study, 1003 patients received one dose of gallium Ga 68 gozetotide injection. Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of <0.5% were diarrhea, dry mouth, injection site reactions, and chills, including injection site hematoma and injection site warmth and chills.

Drug Interactions

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

The safety information provided here is not complete. To learn more, talk about ILLUCCIX with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at illuccix.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please see the Full Prescribing Information.