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

Utility of PSMA PET/CT Imaging

Metastatic PC: Patient Selection for PSMA-Directed Therapy

PSMA PET/CT confirmed patient eligibility for PSMA-directed therapy in the phase 3 VISION trial1

Outcomes support gallium Ga 68 gozetotide PSMA PET/CT imaging as a method to select patients who may be eligible for PSMA-directed therapy1 

 

VISION study design

  • The efficacy of LOCAMETZ for selecting patients for PSMA-directed therapy was established in the randomized, multicenter, open-label, phase 3 VISION study and the VISION reader substudy that evaluated imaging interpretation agreement
  • Using gallium Ga 68 gozetotide PSMA PET/CT imaging, 831* of 1003 patients were identified as eligible for the study and then randomized 2:1 to receive either lutetium Lu 177 vipivotide tetraxetan plus BSOC (n=551) or BSOC alone (n=280)

*The eligibility criteria for PSMA imaging were met in 869 patients. 831 were judged to have met all the trial eligibility criteria, including the PSMA imaging criteria, and were randomized 2:1 to each study arm.1,2

 

Based on their PSMA-positive status and other criteria

Graphic showing 831 of 1003 patients were identified as eligible for the VISION study using gallium Ga 68 gozetotide imaging
Consider a PSMA PET/CT scan to select patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

BSOC, best standard of care; CT, computed tomography; PC, prostate cancer; PET, positron emission tomography; PSMA, prostate-specific membrane antigen.

a The eligibility criteria for PSMA imaging were met in 869 patients. 831 were judged to have met all the trial eligibility criteria, including the PSMA imaging criteria, and were randomized 2:1 to each study arm.1,2

PC With Suspected Metastasis: Before Initial Definitive Therapy

The receptor-based approach of PSMA PET imaging demonstrated strong predictive value when compared against histopathology1

The efficacy of LOCAMETZ in men with suspected metastasis who are candidates for initial definitive therapy has been established based on a study of another formulation of gallium Ga 68 gozetotide1

  • PSMA-PreRP was an open-label, prospective, 2-center study of 325 patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection1
  • Each patient received a single gallium Ga 68 gozetotide PET/CT or PET/MRI from mid-thigh to skull base1
  • For each patient, gallium Ga 68 gozetotide PET results and reference standard histopathology obtained from dissected pelvic lymph nodes were compared by region (left hemipelvis, right hemipelvis, and other)1

 

Compared with reference standard histopathology, PSMA PET imaging demonstrated1:

Image showing 61% positive (95% CI, 41%-81%) and 84% negative (95% CI, 79%-91%) predictive values using gallium Ga 68 gozetotide PSMA PET imaging

MRI, magnetic resonance imaging; PSA, prostate-specfic antigen.

For patients with suspected metastasis who are candidates for initial definitive therapy, consider a PSMA PET/CT scan if you see: Serum PSA of at least 10 ng/mL, tumor stage cT2b or greater, or Gleason score >6

a Based on inclusion criteria for the PSMA-PreRP study. Institutional guidelines may vary.

PC: Suspected Biochemical Recurrence

>9 of 10 evaluable patients with evidence of biochemical recurrence were found to be true positive after PSMA PET imaging1

The efficacy of LOCAMETZ in men with suspected recurrence based on elevated serum PSA level has been established based on studies of another formulation of gallium Ga 68 gozetotide1 

  • PSMA-BCR was an open-label, 2-center prospective study of 635 patients who had biochemical evidence of recurrent prostate cancer after definitive therapy1,3
  • Biochemical recurrence was defined as PSA >0.2 ng/mL more than 6 weeks after prostatectomy or an increase in serum PSA of at least 2 ng/mL above nadir after definitive radiotherapy1,3
  • All patients received a single gallium Ga 68 gozetotide PSMA PET/CT or PSMA PET/MRI from mid-thigh to skull base; 210 had composite standard information collected in a PET-positive region (evaluable patients) consisting of at least 1 of the following: Histopathology, imaging (bone scintigraphy, CT, or MRI) acquired at baseline or within 12 months after gallium Ga 68 gozetotide PET, or serial serum PSA1,3

 

After 3 members of a pool of 9 independent central readers evaluated each PSMA PET/CT and PSMA PET/MRI scan1:

Infographic showing 91% of evaluable patients were found to be true positive and higher PSA equals greater chance of detecting PSMA+ lesions.

Among the pool of 9 readers used in the study, the proportion of patients who were true positive in 1 or more regions ranged from 82% to 97%.

For patients with suspected recurrence, consider a PSMA PET/CT scan if you see: PSA >0.2 ng/mL more than 6 weeks after prostatectomy or increase in serum PSA of at least 2 ng/mL above nadir after definitive radiotherapy

a Based on inclusion criteria for the PSMA-BCR study. Institutional guidelines may vary.

Referring Patients for a PSMA PET/CT Scan

PSMA PET IMAGING* CAN HELP GUIDE MANAGEMENT OF PROSTATE CANCER ACROSS MULTIPLE SETTINGS1,3-6

Consider patients in your practice who could be candidates for a PSMA PET/CT scan and timing

Infographic listing when to consider a PSMA PET/CT scan across multiple prostate cancer settings.

*PSMA PET imaging includes PSMA PET/CT and PSMA PET/MRI.
a Based on inclusion criteria for the PSMA-PreRP study. Institutional guidelines may vary.
b Based on inclusion criteria for the PSMA-BCR study. Institutional guidelines may vary.

REFERRING YOUR PATIENTS FOR A PSMA PET/CT SCAN STARTS WITH 1 SIMPLE STEP

Find the closest LOCAMETZ scanning center and contact information

References: 1. LOCAMETZ [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc; 2022. 2. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. Published online June 23, 2021. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322. 3. 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. 4. 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. 5. 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. 6. 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.

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.