SPOTLIGHT STUDY
Recurrent prostate cancer
Precision diagnostic performance, even at low PSA levels
SPOTLIGHT was an open-label, prospective, Phase 3, multicenter, single-dose imaging study investigating the safety and efficacy of POSLUMA PET imaging in 391 men with suspected prostate cancer recurrence.1,2 Please see additional study design below.
Coprimary endpoints
The coprimary endpoints were patient-level verified detection rate (VDR) and combined region-level positive predictive value (PPV) using histopathology or imaging as a standard of truth.2
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VDR* is the percentage of all patients in whom at least 1 true positive lesion is identified by PSMA PET scan (compared to the standard of truth)2
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Combined region-level PPV† is the proportion of all PET-positive regions‡ with at least 1 true positive lesion identified by PSMA PET scan2
| *VDR | = |
|
| †Combined region-level PPV | = |
|
‡Each patient had a maximum of 3 regions; regions included prostate/prostate bed, pelvic lymph nodes, and other extrapelvic sites, including bone, extrapelvic nodes, viscera, and other soft tissues.
Detection at low PSA
High detection rate, even at low prostate-specific
antigen (PSA) levels1
Overall detection rate by PSA level (majority read; N=389)1
- Overall detection rate by majority read was 83% (322/389)1
- 94% (366/389) of all patients had ≥1 POSLUMA-positive lesion detected by at least 1 reader1
- 78% (211/269) of patients with negative baseline imaging had POSLUMA-avid lesions2
POSLUMA detected lesions as small as 5 mm3
Confirmed results across readers1
In patients with an evaluable scan, across 3 readers and compared to reference imaging* or histopathology (N=389)1†
48% to 51%
of patients had 1 or more verified POSLUMA-positive lesions
46% to 60%
of all POSLUMA-positive regions were confirmed true positive
*Imaging reference standard included CT, MRI, Technetium 99m bone scan, or fluciclovine F 18 PET.
†POSLUMA-positive interpretations were compared to the reference standard using a lesion-to-lesion colocalization method and separate consensus panel. Regions include prostate/prostate bed, pelvic lymph nodes, and other.
Proven high patient-level VDR and combined region-level PPV2
In patients with histopathology available as the standard of truth (N=69)
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82% majority read patient-level PPV in patients with histopathology as a standard of truth2
Change in management
PET imaging with POSLUMA led to a change in clinical
management in evaluable patients3*
89%
of patients
had a change in intended treatment (86/97)*
91%
9%
had a major change in treatment (78/86)†
had a minor change in treatment (8/86)‡
*97 out of 391 men had sufficient information to determine change in treatment. Out of the 167 patients with both a pre-PSMA and post-PSMA patient management plan, 70 had either insufficient or invalid information available with which to determine change in treatment planning.
†Major changes included a change from watchful waiting to salvage or noncurative therapy, a change from salvage to noncurative systemic therapy, a change from salvage or noncurative systemic therapy to watchful waiting, or an alternative major change.
‡Minor changes included modified RT field plan, modified ADT regimen, or an alternative minor change.
ADT=androgen deprivation therapy; RT=radiation therapy.
SPOTLIGHT study design
The SPOTLIGHT study was an open-label, prospective, Phase 3, multicenter, single-dose imaging study investigating the safety and efficacy of POSLUMA PET imaging in 391 men with suspected prostate cancer recurrence. The coprimary endpoints were patient-level verified detection rate (VDR) and combined region-level positive predictive value (PPV) using histopathology or imaging as a standard of truth.1,2
CT=computed tomography; IV=intravenous; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; VDR=verified detection rate.
Demographic and baseline patient characteristics1-3
| Characteristic | All patients with an evaluable scan (N=389) |
| Age (mean) | 68 years (range 43 to 86) |
| Race, n (%) | |
| Black/African American | 61 (16%) |
| White | 293 (75%) |
| Other | 14 (4%) |
| Not reported | 21 (5%) |
| Total Gleason score, n (%) | |
| ≤6 | 39 (10%) |
| 7 | 232 (60%) |
| ≥8 | 103 (26%) |
| Missing | 15 (4%) |
| Grade Group, n (%) | |
| 1 | 39 (10%) |
| 2 | 104 (27%) |
| 3 | 116 (30%) |
| 4 | 40 (10%) |
| 5 | 63 (16%) |
| Missing | 27 (7%) |
| Time since initial diagnosis (median) | 69 months (range 2 to 409 months) |
| Baseline PSA (median) | 1.10 ng/mL (range 0.03 to 134.60 ng/mL) |
| Baseline PSA category, n (%) | |
| <0.5 ng/mL | 121 (31%) |
| ≥0.5 to <1.0 ng/mL | 67 (17%) |
| ≥1.0 to <2.0 ng/mL | 45 (12%) |
| ≥2.0 ng/mL | 156 (40%) |
| Prior therapy, n (%) | |
| With prior prostatectomy | 305 (79%) |
| With radiotherapy | 137 (45%) |
| Without radiotherapy | 168 (55%) |
| Without prior prostatectomy | 84 (22%) |
| Radiotherapy | 76 (90%) |
| Other therapy | 7 (8%) |
| No other therapy | 1 (1%) |
| Administered POSLUMA activity (median) | 306.4 MBq (range 230.1 to 355.2 MBq) |
| 8.28 mCi (range 6.22 to 9.60 mCi) |
References: 1. POSLUMA. Package insert. Blue Earth Diagnostics Ltd; 2023. 2. Jani AB, Ravizzini GC, Gartrell BA, et al. Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in men with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT).J Urol. Published online April 26, 2023. doi:10.1097/JU.0000000000003493 3. Data on file. SPOTLIGHT clinical study report. Blue Earth Diagnostics, Ltd. Oxford, UK.