IMPORTANT SAFETY INFORMATION

 

Risk for Misinterpretation

Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging does not confirm the presence of prostate cancer. ...

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Indication

LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with gallium-68, 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
  • for selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

About PSMA PET/CT Imaging

Characteristics of PSMA

PSMA is a biomarker in prostate cancer1-4

What makes PSMA an ideal target for imaging and treatment?

Graphic showing PSMA as a biomarker

CT, computed tomography; PET, positron emission tomography; PSMA, prostate-specific membrane antigen; PSMA+, PSMA positive.

PSMA PET Imaging in Prostate Cancer

GALLIUM Ga 68 GOZETOTIDE PSMA PET IMAGING HAS BEEN STUDIED IN MULTIPLE TRIALS AND IS APPROVED FOR PATIENTS WITH PROSTATE CANCER5,6,13,14 


  • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated15
  • For patients with suspected metastasis who are candidates for initial definitive therapy15
  • For patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level15

Find a LOCAMETZ scanning center for your patient

References: 1. Davis MI, Bennett MJ, Thomas LM, Bjorkman P. Crystal structure of prostate-specific membrane antigen, a tumor marker and peptidase. Proc Natl Acad Sci U S A. 2005;102(17):5981-5986. 2. Liu H, Rajasekaran, AK, Moy P, et al. Constitutive and antibody-induced internalization of prostate-specific membrane antigen. Cancer Res. 1998;58(18):4055-4060. 3. Rajasaekaran SA, Anilkumar G, Oshima E, et al. A novel cytoplasmic tail MXXXL motif mediates the internalization of prostate-specific membrane antigen. Mol Biol Cell. 2003;14(12):4835-4845. 4. Wright GL Jr, Grob BM, Haley C, et al. Upregulation of prostate-specific membrane antigen after androgen-deprivation therapy. Urology. 1996;48(2):326-334. 5. Fendler WP, Weber M, Iravani A, et al. Prostate-specific membrane antigen ligand positron emission tomography in men with nonmetastatic castration-resistant prostate cancer. Clin Cancer Res. 2019;25(24):7448-7454. 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. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623. 8. Hope TA, Aggarwal R, Chee B, et al. Impact of 68Ga-PSMA-11 PET on management in patients with biochemically recurrent prostate cancer. J Nucl Med. 2017;58(12):1956-1961. 9. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is associated with early PSA recurrence in surgically treated prostate cancer. Prostate. 2011;71(3):281-288. 10. Pomykala KL, Czernin J, Grogan TR, Armstrong W, Williams J, Calais J. Total-Body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. J Nucl Med. 2020;61(3):405-411. 11. Tsourlakis MC, Klein F, Kluth M, et al. PSMA expression is highly homogenous in primary prostate cancer. Appl Immunohistochem Mol Morphol. 2015;23(6):449-455. 12. Troyer JK, Beckett ML, Wright GL Jr. Detection and characterization of the prostate-specific membrane antigen (PSMA) in tissue extracts and body fluids. Int J Cancer. 1995;62(5):552-558. 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. Fendler WP, Calais J, Eiber M, et al. Assessment of 68Ga-PSMA-11 PET accuracy in localizing recurrent prostate cancer: a prospective single-arm clinical trial. JAMA Oncol. 2019;5(6):856-863. 15. LOCAMETZ [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc; 2022.

Indication

LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with gallium-68, 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
  • for selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

 

IMPORTANT SAFETY INFORMATION

Risk for Misinterpretation

Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging 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 nonmalignant processes. 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 LOCAMETZ seems to be affected by serum PSA levels and by site of disease for imaging of biochemically recurrent prostate cancer, and by Gleason score for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy.

Imaging to select patients for lutetium Lu 177 vipivotide tetraxetan therapy

The interpretation of LOCAMETZ PET may differ depending on imaging readers. LOCAMETZ 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 1 tumor lesion compared with judging uptake for all lesions larger than size criteria. Multidisciplinary consultation is recommended, particularly for LOCAMETZ 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 Risk

Gallium Ga 68 gozetotide contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to be well hydrated prior to gallium Ga 68 gozetotide administration and to void immediately prior to and frequently during the first hours after image acquisition to reduce radiation exposure.

Adverse Reactions

Adverse reactions ≥0.5% in the VISION 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.

 

Please see accompanying full Prescribing Information.