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NCT02981368 · OUTCOME

Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions 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 will occur.

What was measured

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

Analysis population: The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.

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)81.2Not reported72.989.5Not 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)81.9Not reported73.790.2Not 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)87.8Not reported80.495.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72.9
        upper Limit
        89.5
        value
        81.2
    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
        73.7
        upper Limit
        90.2
        value
        81.9
    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
        80.4
        upper Limit
        95.3
        value
        87.8
    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
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.
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
The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.
reporting Status
POSTED
time Frame
Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
title
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions 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