Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02981368 · OUTCOME

Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)

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 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.

What was measured

Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).

Analysis population: Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.

Groups in this outcome

Recurrent or Metastatic Prostate Cancer (Cohort B)

Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy 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
Recurrent or Metastatic Prostate Cancer (Cohort B)93

Reported measurements

Central Reader 1

Analysis denominator · Participants

GroupSource count
Recurrent or Metastatic Prostate Cancer (Cohort B)92
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Recurrent or Metastatic Prostate Cancer (Cohort B)98.6Not reported91.60100.00Not reported
Central Reader 2

Analysis denominator · Participants

GroupSource count
Recurrent or Metastatic Prostate Cancer (Cohort B)93
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Recurrent or Metastatic Prostate Cancer (Cohort B)95.8Not reported87.8199.04Not reported
Central Reader 3

Analysis denominator · Participants

GroupSource count
Recurrent or Metastatic Prostate Cancer (Cohort B)92
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Recurrent or Metastatic Prostate Cancer (Cohort B)92.9Not reported83.9897.28Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.60
        upper Limit
        100.00
        value
        98.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.81
        upper Limit
        99.04
        value
        95.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      units
      Participants
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        83.98
        upper Limit
        97.28
        value
        92.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    units
    Participants
description
Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy 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
    Recurrent or Metastatic Prostate Cancer (Cohort B)
param Type
NUMBER
population Description
Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.
reporting Status
POSTED
time Frame
Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
title
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice