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A deeper look into the precision diagnostic performance of POSLUMA

Separate post hoc analyses were conducted to further evaluate the performance of POSLUMA in 2 vital areas:

  1. The detection of recurrence of prostate cancer at low to very low PSA levels
  2. The impact of urinary bladder activity with POSLUMA on clinical evaluation of disease
Low PSA post hoc analysis
Urinary bladder activity post hoc analysis
Low PSA post hoc analysis
Urinary bladder activity post hoc analysis

LOW PSA POST HOC ANALYSIS

POSLUMA detected recurrence at low to very low PSA levels1

SPOTLIGHT study icon

An analysis of 188 patients from the SPOTLIGHT study who had an evaluable POSLUMA scan and who had a baseline PSA <1 ng/mL. Patient- and region-level detection rates by majority read were determined, stratifying detection rates according to the patients’ baseline PSA level.1

PATIENT-LEVEL DETECTION RATE AT PSA <1 ng/mL1

Chart showing patient-level detection rate PSA at <1 ng/mL
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Overall, 68% (128/188) of patients with a PSA <1 ng/mL and 64% (77/121) of patients with a PSA <0.5 ng/mL had a positive POSLUMA scan1

Region-level detection

URINARY ACTIVITY POST HOC ANALYSIS

POSLUMA demonstrated low urinary bladder activity

Low urinary activity icon

This post hoc analysis of 2 pivotal Phase 3 studies was conducted to assess urinary bladder activity associated with POSLUMA and its impact on image interpretation. 712 PET scans were evaluable, 348 from LIGHTHOUSE and 364 from SPOTLIGHT, by 3 board-certified nuclear medicine physicians: quantitatively by 1 and qualitatively by all 3.2,3

Quantitative analysis icon

Quantitative analyses

A circular region of interest was placed over the maximum radioactive diameter in the bladder in the transverse plane to assess SUVmax and SUVmean.2

Quantitative analyses scan

Image from UroToday.4

Qualitative analysis icon

Qualitative analyses

BLADDER ACTIVITY SCORING2

MIPS showing score of 0: No or hardly any urinary activity visible

0=No or hardly any urinary activity visible

MIPS showing score of 1: Urinary activity visible but distinction between urine and disease possible

1=Urinary activity visible but distinction between urine and disease possible

MIPS showing score of 2: Assessment inhibited by urinary activity

2=Assessment inhibited by urinary activity

  • Ureteric activity was defined as the presence or absence of a stasis of urine2
  • Halo artifact was defined as the presence or absence of a gross photopenic region extending significantly beyond the bladder and overlaying the other structures of the pelvis2

For the majority of patients,

POSLUMA demonstrated low urinary bladder activity that did not impact image interpretation

MAJORITY READ

96% exhibited no urinary activity or activity readily distinguishable from disease

of patients (682/712) exhibited either no urinary activity in the bladder or activity that was readily distinguishable from disease.2

Qualitative scoring of urinary bladder activity (majority read)2*

  • 11% (77/712) scored 0
  • 85% (605/712) scored 1
  • 3.4% (24/712) scored 2
  • 1% (6/712) scores were tied

*Using SUV data from Reader 1’s analysis, the median SUVmax for urinary bladder activity scores of 0, 1, 2, or tied were 5.2, 18.8, 25.6, and 7.0, respectively.

WITH POSLUMA

56%

of patients (401/712) had no ureteric activity by majority read2

99.7%

of patients (710/712) did not have halo artifacts present by majority read2

POSLUMA DEMONSTRATED LOW SUV IN THE BLADDER2

Chart showing low SUV in the bladder
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How will reduced urinary bladder activity impact your ability to interpret images?

Next Up

Established safety and tolerability with POSLUMA

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References: 1. Jani A, Michalski JM, Chapin B, Schuster DM. Detection rate of 18F-rhPSMA-7.3 PET in patients with suspected prostate cancer recurrence at PSA levels <1 ng/mL: data from the phase 3 SPOTLIGHT study. Abstract 160. Int J Radiat Oncol Biol Phys. 2023;117(2)(suppl):S35-S36. doi.org/10.1016/j.ijrobp.2023.06.302 2. Kuo PH, Hermsen R, Penny R, Postema EJ. Quantitative and qualitative assessment of urinary activity of 18F-flotufolastat-PET/CT in patients with prostate cancer: a post hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies. Mol Imaging Biol. 2024;26(1):53-60. doi:10.1007/s11307-023-01867-w 3. POSLUMA. Package insert. Blue Earth Diagnostics, Ltd; 2023. 4. SNMMI 2023: post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18F-rhPSMA-7.3 PET/CT. UroToday website. Accessed September 9, 2024. https://www.urotoday.com/conference-highlights/snmmi-2023/snmmi-2023-prostate-cancer/145437-snmmi-2023-post-hoc-analysis-of-the-lighthouse-and-spotlight-studies-to-assess-the-impact-of-urinary-activity-on-interpretation-of-18f-rhpsma-7-3-pet-ct.html