Increase confidence in guiding clinical decisions through early and accurate detection with Illuccix®1,2

Click the patient cases below to review the high-quality images of a PSMA PET scan with Illuccix

Initial staging with Illuccix

Patient history:

  • Prostate biopsy
  • Gleason score: 9
  • PSA level: 22.9 ng/mL

Illuccix imaging detected:

Regional lymph node and bone metastases

Images are from an independent case study. On-file with Telix Pharmaceuticals. Additional information may be provided upon request. The case study is representative of a patient’s experience with Illuccix. Image results may vary. The Efficacy and Safety Profile of Illuccix is described in the accompanying Full Prescribing Information.³

Illuccix at initial staging provides critical information for clinical decision making¹𝄒²

In a prospective study of 197 patients evaluated with 68Ga-PSMA-11a at initial staging or re-staging after definitive therapy²:

  • 69% of patients were restaged
  • 57% of patients had management plan changes

BCR with Illuccix

Patient history:

  • PSA level at diagnosis: 33 ng/mL
  • PSA level post-XBRT: <0.1 ng/mL
  • Positive bone scan with recent PSA level: 5.7 ng/mL

Illuccix imaging detected:

  • Recurrent carcinoma in prostate
  • Metastases in C7 and left iliac crest

Images are from an independent case study. On-file with Telix Pharmaceuticals. Additional information may be provided upon request. The case study is representative of a patient’s experience with Illuccix. Image results may vary. The Efficacy and Safety Profile of Illuccix is described in the accompanying Full Prescribing Information.³

68Ga-PSMA-11a impacts physician treatment decisions for patients with suspected BCR⁴

In a retrospective follow-up of treatment decisions for BCR patients who received 68Ga‑PSMA-11 PET/CT for prostate cancer restaging (N=203)⁴:

  • 60% of patients had a change in management
  • 45% of patients who had treatment changes had complete responses

BCR with lluccix + uEXPLORER

Patient history:

  • Prostate adenocarcinoma with pretreatment PSA levels at 15.67 ng/mL, and a Gleason score of 9
  • All treatment modalities (eg, radiation, chemotherapy, ADT, and surgery) were followed by BCR

Illuccix imaging detected:

Diffuse PSMA PET-positive osseous and lymph node metastases and PSMA PET-negative lung metastases

Images are from an independent case study from BAMF Health, Grand Rapids, MI. The case study is representative of a patient’s experience with Illuccix and the uEXPLORER. Image results may vary. The Efficacy and Safety Profile of Illuccix is described in the accompanying Full Prescribing Information.5

Illuccix combined with uEXPLORER® PET/CT: the cutting edge of prostate cancer detection1,6,7

The world’s first total body 3D PET scanner6-8

uEXPLORER has high sensitivity and has remarkably reduced the scan time to as low as 30 seconds. This innovative technology, combined with Illuccix, has made it possible to detect metastases as small as 2 mm.

a68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.

Indications and Usage

ILLUCCIX, after radiolabeling with Ga-68, is 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 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 the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga-68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). 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% in the VISION study were diarrhea, dry mouth, injection site reactions, 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.

Please note that this information is not comprehensive.

Please see  the Full Prescribing Information.

You are encouraged to report suspected adverse reactions 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 Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

References: 1. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. Sonni I, Eiber M, Fendler WP, et al. Impact of 68Ga-PSMA-11 PET/CT on staging and management of prostate cancer patients in various clinical settings: a prospective single-center study. J Nucl Med. 2020;61(8):1153-1160. 3. Data on File. Patient Case Studies. Telix Pharmaceuticals. 2021. 4. Müller J, Ferraro DA, Muehlematt er UJ, et al. Clinical impact of 68Ga-PSMA-11 PET on patient management and outcome, including all patients referred for an increase in PSA level during the first year after its clinical introduction. Eur J Nucl Med Mol Imaging. 2019;46(4):889-900. 5. Data on File. BAMF Health and Telix complete first total-body PET scans with Illuccix for prostate cancer imaging. Telix Pharmaceuticals. 2022. 6. Spencer BA, Berg E, Schmall JP, et al. Performance evaluation of the uEXPLORER total-body PET/CT scanner based on NEMA NU 2-2018 with additional tests to characterize pet scanners with a long axial field of view. J Nucl Med. 2020;62(6):861‑870. 7. Cherry SR, Jones T, Karp JS, Qi J, Moses WW, Badawi RD. Total-body PET: Maximizing sensitivity to create new opportunities for clinical research and patient care. J Nucl Med. 2017;59(1):3-12. 8. Kulkarni HR, Faasse T, Mulder K, et al. 30-second acquisition for Ga-68 PSMA-11 total-body PET/CT impacts prostate cancer management. Presented at Society of Nuclear Medicine and Molecular Imaging; January 26-28, 2023; San Francisco, CA.