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 Prescribing Information
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Call Siemens’ PETNET Solutions Inc., a Siemens Healthineers company, at 1-877-473-8638

LIGHTHOUSE STUDY
Initial staging for patients with increased-risk prostate cancer prior to initial therapy

Precision data to inform clinical decision-making

LIGHTHOUSE study icon LIGHTHOUSE study icon

LIGHTHOUSE was an open-label, prospective, Phase 3, multicenter, single-dose imaging study uniquely assessing the safety and efficacy of POSLUMA PET imaging in 356 men with newly diagnosed unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer.1-3 Please see additional study design below.

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coprimary endpoints

The coprimary endpoints were sensitivity and specificity of POSLUMA PET imaging for detecting N1 disease in concordance with histopathology of the pelvic lymph node dissection.2,3

Proven sensitivity and specificity compared to histopathology1-3

Out of 296 patients with sufficient histopathology data for evaluation of the pelvic lymph nodes, across 3 readers1

SPECIFICITY

Patient-level

93% to 97%

Across 3 readers

SENSITIVITY

Patient-level

23% to 30%

Across 3 readers

  • Nearly one-third of patients enrolled (115/356) were diagnosed with unfavorable intermediate-risk prostate cancer1

Majority read sensitivity and specificity compared to histopathology (N=296)2,3

SPECIFICITY

98 percent

Unfavorable intermediate-risk prostate cancer

Majority read
(78/80; 95% CI: 91%, 100%)

95 percent

High-risk or very high-risk prostate cancer

Majority read
(139/146; 95% CI: 90%, 98%)

SENSITIVITY

16 percent

Unfavorable intermediate-risk prostate cancer

Majority read
(3/19; 95% CI: 3%, 40%)

27 percent

High-risk or very high-risk prostate cancer

Majority read
(14/51; 95% CI: 16%, 42%)

Histopathology as the standard of truth

PET may detect lesions as small as 4 to 5 mm, but histopathology can detect micrometastases.4,5

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HOW DOES DISTANT METASTATIC DISEASE IMPACT YOUR INITIAL TREATMENT PLAN?

In recent years, the rate of identified metastatic prostate cancer cases has risen from 4% to 8% with fewer than one-third of men surviving 5 years after a diagnosis of distant metastatic disease. However, survival is on the rise, which may reflect changes in clinical management and treatment options.6‑8 POSLUMA’s proven metastatic lesion detection can provide crucial information to guide a patient’s treatment plan.1,3

N1 AND M1 DETECTION

POSLUMA revealed pelvic lymph node and distant metastatic disease, a crucial staging distinction3

POSLUMA detected N1 and M1 lesions, even in patients with unfavorable intermediate-risk prostate cancer.3

*Percent PET positivity.

MAJORITY READ

MAJORITY READ

POSLUMA detected N1 and M1 lesions, even in patients with unfavorable intermediate-risk prostate cancer.3

*Percent PET positivity.

N1 disease

13%
of patients

had ≥1 pelvic lymph node metastasis (N1) detected3*
(47/352; 95% CI: 10%, 17%)

M1 disease

17%
of patients

of patients had ≥1 extrapelvic site metastasis (M1) detected3*
(61/352; 95% CI: 14%, 22%)

VERIFIED DETECTION RATE

Detection of distant metastatic disease impacts risk
assessment and treatment planning3

Icon of 9 black stick figures and 1 red stick figure

1 in 10 patients

(34/352) had at least 1 verified distant metastatic lesion revealed by POSLUMA1*

56% (34/61; 95% CI: 42% to 68%) of patients with ≥1 distant metastatic lesion detected were confirmed by majority read and a reference standard.1*

 

*Histopathology or confirmatory imaging was used as the standard of truth for M1 disease evaluation.

LIGHTHOUSE study design

    Expand to see full study design

    The LIGHTHOUSE study was an open-label, prospective, Phase 3, single-dose imaging study uniquely assessing the safety and efficacy of POSLUMA PET imaging in 356 men with newly diagnosed unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer. Three central, blinded readers independently evaluated each POSLUMA scan for the presence and location of prostate cancer compared to pelvic lymph node dissection (PLND). The coprimary endpoints were sensitivity and specificity of POSLUMA PET imaging for detecting N1 disease in concordance with histopathology of the PLND.1-3

    Chart describing the patient population for the SPOTLIGHT study, as well as explaining the POSLUMA PET/CT scans and listing the coprimary endpoints and select additional endpoints

    IV=intravenous; PPV=positive predictive value; RP=radical prostatectomy; VDR=verified detection rate.

     

    Demographic and baseline patient characteristics1,3

       
    Characteristic Full analysis set (N=356)
    Age (mean) 65 years (range 46 to 83)
    Race, n (%)  
    Black/African American 30 (8%)
    White 289 (81%)
    Other 4 (1%)
    Not reported 33 (9%)
    Total Gleason score, n (%)  
    ≤6 6 (2%)
    7 160 (45%)
    8 87 (24%)
    9 97 (27%)
    10 6 (2%)
    Last PSA measurement (median) 8.81 ng/mL (range 1.15 to 120.00 ng/mL)
    Baseline PSA category, n (%)  
    0 to 0.5 ng/mL 0 (0%)
    >0.5 to 1.0 ng/mL 0 (0%)
    >1.0 to 2.0 ng/mL 2 (1%)
    >2.0 to 5.0 ng/mL 62 (17%)
    >5.0 to 10.0 ng/mL 134 (38%)
    >10.0 ng/mL 158 (44%)
    Baseline risk category  
    High-risk or very high-risk 241 (68%)
    Intermediate-risk 115 (32%)
    Baseline imaging,* n (%)  
    Pelvic lymph node  
    Positive interpretation 21 (6%)
    Negative interpretation 297 (83%)
    Extrapelvic sites  
    Positive interpretation 20 (6%)
    Negative interpretation 335 (94%)

    *Baseline imaging included CT, MRI, and bone scan.

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    References: 1. POSLUMA. Package insert. Blue Earth Diagnostics Ltd; 2023. 2. Chapin B; LIGHTHOUSE Study Group. Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer: results from a phase 3, prospective, multicenter study (LIGHTHOUSE). Poster presented at: 23rd Annual Meeting of the Society of Urologic Oncology. December 1, 2022. San Diego, CA. 3. Data on file. LIGHTHOUSE clinical study report. Blue Earth Diagnostics, Ltd. Oxford, UK. 4. Magi-Galluzzi C. Prostate cancer: diagnostic criteria and role of immunohistochemistry. Mod Pathol. 2018;31(S1):S12-S21. doi:10.1038/modpathol.2017.139 5. Adler S, Seidel J, Choyke P, et al. Minimum lesion detectability as a measure of PET system performance. EJNMMI Phys. 2017;4(1):13. doi:10.1186/s40658-017-0179-2 6. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708 7. American Cancer Society. Cancer Facts & Figures 2022. Atlanta, GA: American Cancer Society; 2022. Accessed December 16, 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancerfacts-figures/cancer-facts-figures-2022.html 8. Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017. MMWR Morb Mortal Wkly Rep. 2020;69(41):1473-1480. doi:10.15585/mmwr.mm6941a1

    Indication

    POSLUMA® (flotufolastat F 18) injection 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

    INDICATION | IMPORTANT SAFETY INFORMATION

    INDICATION

    POSLUMA® (flotufolastat F 18) injection 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

    IMPORTANT SAFETY INFORMATION

    • Image interpretation errors can occur with POSLUMA 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 POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
    • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
    • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
    • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
    • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

    To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

    • Image interpretation errors can occur with POSLUMA 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 POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
    • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
    • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
    • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
    • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

    To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

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