Description:
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.
Title
- Brief Title: Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)
- Official Title: 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 Newly Diagnosed Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
BED-PSMA-301
- NCT ID:
NCT04186819
Conditions
Interventions
Drug | Synonyms | Arms |
---|
rhPSMA-7.3 (18F) Injection | | Patients |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Patients | Experimental | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan | - rhPSMA-7.3 (18F) Injection
|
Eligibility Criteria
Inclusion Criteria:
1. Patient is male and aged >18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node
dissection (PLND).
Exclusion Criteria:
1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24
hours prior to the PET scan.
2. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy
(ADT).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Sensitivity of rhPSMA-7.3 (18F) |
Time Frame: | 90 days |
Safety Issue: | |
Description: | Sensitivity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level.
At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level. |
Secondary Outcome Measures
Measure: | Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. |
Time Frame: | 90 days |
Safety Issue: | |
Description: | Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans. |
Measure: | Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. |
Time Frame: | 90 days |
Safety Issue: | |
Description: | Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans. |
Measure: | Number of participants with treatment-related adverse events as classified by MedDRA |
Time Frame: | 90 days |
Safety Issue: | |
Description: | Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Blue Earth Diagnostics |
Trial Keywords
- Primary Prostate Cancer
- Diagnostic
- Prostate Specific Membrane Antigen (PSMA)
- Positron Emission Tomography (PET) Scan
Last Updated
March 9, 2021