TriangleNCT02981368 · OUTCOME
Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
What was measured
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Analysis population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
Groups in this outcome
High Risk Prostate Cancer (Cohort A)
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
| Group | Source count |
|---|---|
| High Risk Prostate Cancer (Cohort A) | 252 |
Reported measurements
Central Reader 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | 97.9 | Not reported | 94.52 | 99.37 | Not reported |
Central Reader 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | 98.9 | Not reported | 96.00 | 99.96 | Not reported |
Central Reader 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | 96.3 | Not reported | 93.64 | 98.99 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 94.52
- upper Limit
- 99.37
- value
- 97.9
- title
- Central Reader 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96.00
- upper Limit
- 99.96
- value
- 98.9
- title
- Central Reader 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 93.64
- upper Limit
- 98.99
- value
- 96.3
- title
- Central Reader 3
- denoms
- counts
- group Id
- OG000
- value
- 252
- units
- Participants
- description
- The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
- id
- OG000
- title
- High Risk Prostate Cancer (Cohort A)
- param Type
- NUMBER
- population Description
- The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
- reporting Status
- POSTED
- time Frame
- Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
- title
- Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice