Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04186845 · ClinicalTrials.gov registry record · Phase 3
Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence
A Phase 3 study, sponsored by Blue Earth Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 391
- Enrollment target
NCT04186845: Completed Phase 3 study, sponsored by Blue Earth Diagnostics.
NCT04186845 is a Phase 3 study that has completed, run by Blue Earth Diagnostics. The registered enrollment target is 391 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04186845, a Phase 3 study, has completed, sponsored by Blue Earth Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 391 participants
- Enrollment target
Study 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.
Primary Outcome
The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.
Interventions
- DRUG rhPSMA-7.3 (18F) Injection
- DIAGNOSTIC_TEST Positron emission tomography scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 391 participants |
| Start Date | 2020-05-04 |
| Est. Completion | 2021-04-28 |
| Phase | Phase 3 |
What the finished NCT04186845 record still lists
NCT04186845 is an interventional study that assigns participants to a tested intervention. The registered 391 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which rhPSMA-7.3 (18F) Injection is the first listed.
NCT04186845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04186845 about?
NCT04186845 is a clinical study titled "Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence". 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...
What is the current status of trial NCT04186845?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 391 participants. The study started on 2020-05-04. Estimated completion is 2021-04-28.
What interventions are being tested in trial NCT04186845?
The interventions under investigation include: rhPSMA-7.3 (18F) Injection (DRUG), Positron emission tomography scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04186845?
This trial is sponsored by Blue Earth Diagnostics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04186845's enrollment target sits among peer trials
391 968th of 2000 higher than 1,033 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06397703 · 392 participants · Phase 2
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
- NCT06625775 · 392 participants · Phase 1
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
- NCT07220967 · 392 participants · Phase 4
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
- NCT07290036 · 392 participants · Phase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI