Phase 2
N=18
A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02142608 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging — 17; 8 number of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BR55 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Bracco Diagnostics, Inc
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging |
17; 8 | — |
| SECONDARY Number of Participants With Adverse Events |
1; 1; 0; 0; 0; 0 | — |
Summary
Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results
Eligibility Criteria
Inclusion Criteria
- Male, age between 50-70 years old
- Increased Prostate-Specific Antigen (PSA) level >4 ng/mL
- Known prostate cancer
- Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
- Provided written informed consent and willing to comply with protocol requirements
Exclusion Criteria
- Documented acute prostatitis or urinary tract infections
- Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease
- History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
- Severe cardiac rhythm disorders within the last 7 days
- Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
- Received a prostate biopsy procedure within 30 days before admission into the study
- Determined by investigator to be clinically unsuitable for the study
- Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days
Data sourced from ClinicalTrials.gov (NCT02142608). 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.