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NCT02981368 · OUTCOME

Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Source last updated 2021-08-09

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

Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)252

Reported measurements

Central Reader 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)83.8Not reported78.988.6Not reported
Central Reader 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)81.4Not reported76.486.4Not reported
Central Reader 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)83.2Not reported78.288.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.9
        upper Limit
        88.6
        value
        83.8
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        76.4
        upper Limit
        86.4
        value
        81.4
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.2
        upper Limit
        88.1
        value
        83.2
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      252
    units
    Participants
description
Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
dispersion Type
95% Confidence Interval
groups
  1. 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
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice