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.

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 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.

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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

Can give doctors greater clarity regarding the extent of your prostate cancer

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

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

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.

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 most common side effects that occurred in less than 1% of people were nausea, diarrhea, and dizziness. If you are scheduled to have a PET scan with Illuccix and have any concerns, talk to your doctor or a member of your care team.

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Indications and Usage

Illuccix®, after radiolabeling with gallium-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

Important Safety Information

Warnings and Precautions

Risk for Misdiagnosis

Image interpretation errors can occur with gallium-68 gozetotide 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 gallium-68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium-68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium-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 gallium-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

Important Safety Information

Warnings and Precautions

Risk for Misdiagnosis

Image interpretation errors can occur with gallium-68 gozetotide 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 gallium-68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium-68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium-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.

Radiation Risks

Gallium-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 health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The safety of gallium-68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium-68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

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-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium-68 gozetotide PET has not been established.

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 full Prescribing Information.