Prostate Cancer
Conditions
Keywords
Prostate cancer, Ultrasound Imaging
Brief 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
Detailed description
This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.
Interventions
DRUGBR55
Ultrasound contrast agent
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging | Within 30 minutes after administration of BR55 | To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 24 hours post-dose | To obtain safety data in subjects administered BR55 |
Countries
France, United States
Participant flow
Recruitment details
19 patients were recruited, but only 18 were dosed. Of the 18 dosed, 4 were training cases evaluated for safety only. Of the remaining 14 patients, 1 had no evaluable images; therefore, only 13 patients were included in the Efficacy Population.
Pre-assignment details
One participant was not dosed with BR55. Patient signed informed consent but did not receive investigational product. During pre-dose safety evaluations, it was discovered that patient may have potentially clinical significant abnormal ECGs (atrial fibrillation).
Participants by arm
| Arm | Count |
|---|---|
| BR55 All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | BR55 |
|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 4.68 |
| Age, Customized 18-64 years | 12 Participants |
| Age, Customized >= 65 years | 6 Participants |
| Height | 172.6 cm STANDARD_DEVIATION 8.71 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 16 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
| Weight | 83.62 kg STANDARD_DEVIATION 15.573 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Time frame: Within 30 minutes after administration of BR55
Population: BR55 binding level versus Gleason score in malignant lesions from off-site histopathology
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BR55 | Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging | Gleason score ≥7 | 17 number of lesions |
| BR55 | Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging | With binding | 8 number of lesions |
Secondary
Number of Participants With Adverse Events
To obtain safety data in subjects administered BR55
Time frame: 24 hours post-dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BR55 | Number of Participants With Adverse Events | Number of subjects with AEs | 1 participants |
| BR55 | Number of Participants With Adverse Events | Number of subjects with AEs by intensity - Mild | 1 participants |
| BR55 | Number of Participants With Adverse Events | Number of subjects with AEs by intensity -Moderate | 0 participants |
| BR55 | Number of Participants With Adverse Events | Number of subjects with AEs by intensity - Severe | 0 participants |
| BR55 | Number of Participants With Adverse Events | Number of subjects with serious AEs | 0 participants |
| BR55 | Number of Participants With Adverse Events | Number of subjects who discontinued due to AEs | 0 participants |
| BR55 | Number of Participants With Adverse Events | Number of deaths | 0 participants |