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Confidence in PSMA PET Imaging1

68Ga-PSMA-11 (Illuccix®) Recommended by AUA/SUO, SNMMI, and National Comprehensive Cancer Network® (NCCN®) (Preferreda)2-4

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Clinical
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Pinpoint micrometastases at the earliest signs in a broad range of patients1

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Trust high-quality images across vital regions, with scan time ≤30 minutes5-8

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68Ga-PSMA-11 (Illuccix) is recommended by AUA/SUO, NCCN, and SNMMI/EANM procedure guidelines2-4

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PSMA imaging is changing the landscape of advanced prostate cancer.

–AUA Guideline Recommendations

aInterventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.4

Illuccix helps detect the extent of disease and guide management across prostate cancer stages1,13-16

Pinpoint micrometastatic disease as small as 2mm with Illuccix1,17-19

Illuccix indicated across prostate cancer stages1

Mobile graph of diagnostic performance demonstrated across prostate cancer stages in clinical trials
Graph of diagnostic performance demonstrated across prostate cancer stages in clinical trials

With suspected metastasis who are candidates for initial definitive therapy

With suspected recurrence based on elevated serum PSA level

For selection of patents with metastatic prostate cancer, for whom PSMA-directed 177Lu radioligand therapy is indicated

BCR, biochemical recurrence; EANM, European Association of Nuclear Medicine; mCRPC, metastatic castration-resistant prostate cancer; NCCN, National Comprehensive Cancer Network; nmCRPC, non-metastatic castration-resistant prostate cancer; SNMMI, Society of Nuclear Medicine and Molecular Imaging.

Mechanism of Action

68Ga harnesses the power of PSMA PET/CT

PSMA has become an important development in prostate cancer diagnostics. PSMA is overexpressed in primary and metastatic prostate cancer cells, but its expression is low or absent in healthy cells, which makes PSMA an ideal target for prostate cancer imaging20-22:

  • More than 90% of primary lesions show moderate to high PSMA expression23
  • Higher PSMA levels are associated with advanced disease and increased PSA levels20

68Ga-PSMA-11 is a radiotracer that binds with high affinity to PSMA and in doing so can reveal prostate cancer cells in the body.20 Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium 68 (Ga 68) is a β+ emitting radionuclide that allows positron emission tomography.1

Watch video. Thumbnail of gallium Ga 68 gozetotide mechanism of action

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. Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023). J Urol. 2023;209(6):1082-1090. 3. Fendler WP, Eiber M, Beheshti M, et al. PSMA PET/CT: joint EANM procedure guideline/SNMMI procedure standard for prostate cancer imaging 2.0. Eur J Nucl Med Mol Imaging. 2023;50(5):1466-1486. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed July 25, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Hope TA, Eiber M, Armstrong WR, et al. Diagnostic accuracy of ⁶⁸Ga-PSMA-11 PET for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: a multicenter prospective phase 3 imaging trial. JAMA Oncol. 2021;7(11):1635-1642. 6. Hofman MS, Lawrentschuk N, Francis RJ, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395(10231):1208-1216. 7. Velikyan I. ⁶⁸Ga-based radiopharmaceuticals: production and application relationship. Molecules. 2015;20(7):12913-12943. 8. Data on File. Isotope Decay Rates. Telix Pharmaceuticals. 2022. 9. Massat MB. Nuclear medicine prepares for greater ⁶⁸Ga demand. Appl Radiol. 2021;50(2):30-31. https://appliedradiology.com/articles/nuclear-medicine-prepares-for-greater-ga-68-demand. Accessed June 9, 2023. 10. Data on File. Activated Sites. Telix Pharmaceuticals. 2023. 11. Data on File. Distribution Metrics. Telix Pharmaceuticals. 2023. 12. Data on File. Delivery. Telix Pharmaceuticals. 2022. 13. 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. 14. 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. 15. Roach PJ, Frances R, Emmett L, et al. The impact of ⁶⁸Ga-PSMA PET/CT on management intent in prostate cancer: results of an Australian prospective multicenter study. J Nucl Med. 2018;59(1):82–88. 16. Koerber SA, Will L, Kratochwil C, et al. ⁶⁸Ga-PSMA-11 PET/CT in primary and recurrent prostate carcinoma: implications for radiotherapeutic management in 121 patients. J Nucl Med. 2019;60(2):234-240. 17. Giesel FL, Fiedler H, Stefanova M, et al. PSMA PET/CT with Glu-urea-Lys-(Ahx)-[68Ga(HBED-CC)] versus 3D CT volumetric lymph node assessment in recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015;42(12):1794-1800. 18. van Leeuwen PJ, Emmett L, Ho B, et al. Prospective evaluation of ⁶⁸Gallium-prostate-specific membrane antigen positron emission tomography/computed tomography for preoperative lymph node staging in prostate cancer. BJU Int. 2017(2);119:209-215. 19. Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1758835919876828. 20. Dorff TB, Fanti S, Farolfi A, Reiter RE, Sadun TY, Sartor O. The evolving role of prostate-specific membrane antigen-based diagnostics and therapeutics in prostate cancer. Am Soc Clin Oncol Educ Book. 2019;39:321-330. 21. Eiber M, Fendler WP, Rowe SP, et al. Prostate-specific membrane antigen ligands for imaging and therapy. J Nucl Med. 2017;58(suppl 2):67S-76S. 22. Ristau BT, O’Keefe DS, Bacich DJ. The prostate-specific membrane antigen: lessons and current clinical implications from 20 years of research. Urol Oncol. 2014;32(3):272-279. 23. Maurer T, Gschwend JE, Rauscher I, et al. Diagnostic efficacy of (68)Gallium-PSMA positron emission tomography compared to conventional imaging for lymph node staging of 130 consecutive patients with intermediate to high risk prostate cancer. J Urol. 2016;195(5):1436-1443.

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