Prostatic Neoplasms
Conditions
Keywords
observational study
Brief summary
This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.
Detailed description
This study will collect clinical data from consenting patients (unless a HIPAA waiver or equivalent was granted) who received the PET radiotracer Fluciclovine 18F (FACBC) (a synthetic amino acid analog) for imaging of patients with various cancers at participating sites in the US and Europe. Data collection will cover baseline medical history and medications in all patients. The result of PET radiotracer and other imaging findings, and reports of histopathology from biopsied tissue (where available) and in a time window relevant to the use of PET imaging in the diagnosis of primary/recurrent prostate cancer will be recorded. In all subjects, with regards to safety monitoring, available data for physical examination, vital signs and laboratory test results will be collected from 28 days prior to and out to a 35 day window after Fluciclovine 18F (FACBC) administration. The major goals of the investigation are to consolidate the safety profile of Fluciclovine 18F (FACBC), to evaluate its use in the detection of local and extraprostatic recurrence of prostate cancer and to evaluate its ability to detect malignancy in patients undergoing screening for primary prostate cancer.
Interventions
RADIATIONFluciclovine (18F)
Not applicable. This is an observational study.
Sponsors
Blue Earth Diagnostics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient managed by a site at which ethical committee approval for retrospective data collection under this protocol has been received * Patient has received at least one injection of fluciclovine (18F) for the detection of a malignant tumour at any location
Exclusion criteria
* Subjects will be excluded from the analyses if any of the following criteria are met: * Patients participating in clinical trials or open access programmes at countries or sites not participating in this study. * Patients managed at sites without ethical committee approval for retrospective data collection under this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Up to 35 days post Fluciclovine 18F | Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events |
| Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Up to 1 year post Fluciclovine 18F | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. |
| Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Up to 1 year post Fluciclovine 18F | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Up to 1 year post Fluciclovine 18F | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. |
| Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Up to 1 year post Fluciclovine 18F | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. |
Countries
Italy, Norway, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Recurrent Prostate Cancer Recurrent Prostate Cancer | 596 |
| Primary Prostate Cancer Primary Prostate Cancer | 95 |
| Other Cancers Other Cancers | 23 |
| Total | 714 |
Baseline characteristics
| Characteristic | Recurrent Prostate Cancer | Primary Prostate Cancer | Other Cancers | Total |
|---|---|---|---|---|
| Age, Continuous | 67 Years | 65 Years | 61 Years | 66 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 0 Participants | 3 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 382 Participants | 95 Participants | 3 Participants | 480 Participants |
| Race (NIH/OMB) White | 186 Participants | 0 Participants | 17 Participants | 203 Participants |
| Region of Enrollment Italy | 88 Participants | 0 Participants | 0 Participants | 88 Participants |
| Region of Enrollment Norway | 371 Participants | 85 Participants | 2 Participants | 458 Participants |
| Region of Enrollment United States | 137 Participants | 10 Participants | 21 Participants | 168 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 16 Participants | 16 Participants |
| Sex: Female, Male Male | 596 Participants | 95 Participants | 7 Participants | 698 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 714 |
| other Total, other adverse events | 9 / 714 |
| serious Total, serious adverse events | 2 / 714 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Time frame: Up to 35 days post Fluciclovine 18F
Population: Patients who have received at least one dose of Fluciclovine 18F
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recurrent Prostate Cancer | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment Emergent Adverse Events | 32 Participants |
| Recurrent Prostate Cancer | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment Emergent Serious Adverse Events | 1 Participants |
| Primary Prostate Cancer | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment Emergent Adverse Events | 2 Participants |
| Primary Prostate Cancer | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment Emergent Serious Adverse Events | 1 Participants |
| Other Cancers | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment Emergent Adverse Events | 8 Participants |
| Other Cancers | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment Emergent Serious Adverse Events | 0 Participants |
Primary
Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Time frame: Up to 1 year post Fluciclovine 18F
Population: Standard of truth was histology. For the prostate/bed region standard TRUS/biopsy or MRI/TRUS fusion biopsy was used to establish truth while blinded to PET findings.~When feasible, clinically relevant 18F-fluciclovine positive extraprostatic areas underwent directed biopsy based on cognitive fusion of the PET/CT data with biopsy technique.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recurrent Prostate Cancer | Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Subject PPV | 82.4 Percentage of participants |
| Recurrent Prostate Cancer | Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Extraprostatic Region PPV | 92.3 Percentage of participants |
| Recurrent Prostate Cancer | Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Prostate & Prostate Bed Region PPV | 71.8 Percentage of participants |
Primary
Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Time frame: Up to 1 year post Fluciclovine 18F
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Recurrent Prostate Cancer | Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | 100 Percentage of participants |
Secondary
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.
Time frame: Up to 1 year post Fluciclovine 18F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recurrent Prostate Cancer | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Detection Rate | 82.4 Percentages |
| Recurrent Prostate Cancer | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Sensitivity | 94.7 Percentages |
| Recurrent Prostate Cancer | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Specificity | 54.8 Percentages |
| Recurrent Prostate Cancer | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Negative Predictive Value | 77.3 Percentages |
Secondary
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.
Time frame: Up to 1 year post Fluciclovine 18F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recurrent Prostate Cancer | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Detection Rate | 93.4 Percentage of participants |
| Recurrent Prostate Cancer | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Sensitivity | 93.4 Percentage of participants |