Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 296 MBq/mL to 5,846 MBq/mL [8 mCi/mL to 158 mCi/mL]) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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
- Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Latest News
Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- In the LIGHTHOUSE study involving newly diagnosed prostate cancer patients, the sensitivity for detecting pelvic lymph node (PLN) metastases was reported as 30%, with a 95% confidence interval (CI) of 19.6% to 42.1%. for Reader 1, with specificity exceeding the prespecified threshold at 93%, with a 95% CI of 88.8% to 95.9%. Sensitivity was notably higher in high-risk/very-high-risk (VHR) patients (24-33%) compared to unfavorable intermediate-risk patients (16-21%).
- The SPOTLIGHT study demonstrated an overall detection rate of 83% among 389 patients with evaluable scans, while the verified detection rate ranged from 51% (95% CI 46.1-56.6) to 54% (95% CI 48.8-59.3%), exceeding the prespecified threshold. In the subset with histopathology as the standard of truth, the verified detection rate was 81% (95% CI 69.9-89.6%).
- Both studies included specific population types: the LIGHTHOUSE study focused on newly diagnosed prostate cancer patients planned for prostatectomy, and the SPOTLIGHT study targeted patients with prostate cancer recurrence, highlighting that verified detection rates were higher in the histopathology standard of truth subgroup.
- In the LIGHTHOUSE study involving newly diagnosed prostate cancer patients, no serious adverse events were observed, and the safety profile remained consistent across different risk stratifications, including unfavorable intermediate-risk (UIR) and high-/VHR patients.
- The SPOTLIGHT study identified no significant safety concerns, and while it did not specify differences in safety outcomes across subgroups, the overall safety data suggest that the treatment was well tolerated among patients with prostate cancer recurrence.
- The LIGHTHOUSE study included newly diagnosed prostate cancer patients planned for prostatectomy, identifying that sensitivity for detecting PLN metastases was higher among high-/VHR patients (24-33%) compared to UIR patients (16-21%). The SPOTLIGHT study focused on patients with prostate cancer recurrence, showing higher verified detection rates and combined region-level positive predictive values in the subgroup with histopathology standard of truth, with a verified detection rate of 81% (95% CI 69.9-89.6).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Posluma (flotufolastat F 18) Prescribing Information. | 2023 | Blue Earth Diagnostics Ltd., Oxford, UK |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). | 352Subjects F: 0% M: 100% | 2023 | European Urology |
| Diagnostic Performance and Safety of 18F-rhPSMA-7.3 Positron Emission Tomography in Men With Suspected Prostate Cancer Recurrence: Results From a Phase 3, Prospective, Multicenter Study (SPOTLIGHT). | 389Subjects F: 0% M: 100% | 2023 | The Journal of Urology |
Sex Distribution:
F:0%
M:100%
352Subjects
Year:
2023
Source:European Urology
Sex Distribution:
F:0%
M:100%
389Subjects
Year:
2023
Source:The Journal of Urology