Phase 3
N=391
Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04186845 ↗Enrolled (actual)
391
Serious AEs
0.5%
Results posted
Feb 2025
Primary outcome: Primary: Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT — 54.1; 51.4; 51.6; 46.2 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rhPSMA-7.3 (18F) Injection (Drug); Positron emission tomography scan (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Blue Earth Diagnostics
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT |
54.1; 51.4; 51.6; 46.2; 60.3; 52.6 | — |
| SECONDARY Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging |
46.8; 45.2; 45.6; 39.7; 56.2; 46.8 | — |
| SECONDARY Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available |
75.4; 49.2; 76.8; 45.5; 73.9; 46.5 | — |
| SECONDARY Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level |
29.5; 44.4; 65.1; 72.7; 61.1; 80.7 | — |
| SECONDARY CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other |
16.7; 21.6; 29.2; 13.1; 19.4; 30.6 | — |
| SECONDARY Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes) |
6.6; 46.7; 4.8; 31.7; 10.2 | — |
| SECONDARY Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers |
0.29; 0.38; 0.50 | — |
| SECONDARY Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level |
29.1; 37.1; 45.6; 57.7; 57.9; 59.6 | — |
| SECONDARY Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available |
60.9; 42.4; 67.0; 57.9; 62.6; 49.5 | — |
Summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.
Eligibility Criteria
Inclusion Criteria
- Patient is male and aged >18 years old.
- History of localized adenocarcinoma of the prostate with prior curative intent treatment.
- An elevated PSA, clinically suspicious for biochemically recurrent disease:
- Following Radical Prostatectomy: PSA >0.2 ng/mL
- Following Radiotherapy: nadir +2 ng/mL.
- Potentially eligible for salvage therapy with curative intent.
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 Androgen Deprivation Therapy (ADT).
Data sourced from ClinicalTrials.gov (NCT04186845). 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.