Phase 3
Completed N=356
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
Source: ClinicalTrials.gov NCT04186819 ↗Enrolled (actual)
356
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Specificity — 92.9; 93.8; 96.9 percentage
◆ Published Evidence
Established
95citations · ~32 / year
Diagnostic Performance and Safety of Positron Emission Tomography with <sup>18</sup>F-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).
Summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
Linked Publications
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Diagnostic Performance and Safety of Positron Emission Tomography with <sup>18</sup>F-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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity |
92.9; 93.8; 96.9 | — |
| PRIMARY Sensitivity |
30; 27.1; 22.9 | — |
| SECONDARY Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) |
9.9; 14.2; 10.2 | — |
| SECONDARY Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) |
8.8; 13.0; 8.5 | — |
| SECONDARY Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) |
56.8; 62.5; 57.6; 51.0; 69.6; 57.1 | — |
| SECONDARY PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) |
48.6; 54.5; 65.2 | — |
| SECONDARY NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) |
81.3; 80.8; 79.9 | — |
| SECONDARY The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) |
5.1; 8.2; 4.3; 12.2; 3.7; 8.0 | — |
| SECONDARY The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b) |
2.6 | — |
| SECONDARY Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) |
97.7; 95.2; 96.9; 100; 100; 95.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is male and aged >18 years old.
- Histologically confirmed adenocarcinoma of the prostate.
- Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
Exclusion Criteria
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
- Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).
Data sourced from ClinicalTrials.gov (NCT04186819) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.