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NCT02981368 · OUTCOME

Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)

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
MEAN
Unit
degrees Celsius
Interval / dispersion
Standard Deviation
Time frame
Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Analysis population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).

Groups in this outcome

High Risk Prostate Cancer (Cohort A)

High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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.

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 (Cohort B) 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)266
Recurrent or Metastatic Prostate Cancer (Cohort B)117

Reported measurements

Temperature: Baseline (Actual)

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)266
Recurrent or Metastatic Prostate Cancer (Cohort B)117
Values in degrees Celsius · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)36.580.433Not reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B)36.560.338Not reportedNot reportedNot reported
Temperature: Post-dosing (Actual)

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)263
Recurrent or Metastatic Prostate Cancer (Cohort B)113
Values in degrees Celsius · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)36.500.479Not reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B)36.590.309Not reportedNot reportedNot reported
Temperature: Change from Baseline

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)261
Recurrent or Metastatic Prostate Cancer (Cohort B)113
Values in degrees Celsius · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)-0.080.496Not reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B)0.030.265Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.433
        value
        36.58
      2. group Id
        OG001
        spread
        0.338
        value
        36.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        266
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Temperature: Baseline (Actual)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.479
        value
        36.50
      2. group Id
        OG001
        spread
        0.309
        value
        36.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        263
      2. group Id
        OG001
        value
        113
      units
      Participants
    title
    Temperature: Post-dosing (Actual)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.496
        value
        -0.08
      2. group Id
        OG001
        spread
        0.265
        value
        0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        261
      2. group Id
        OG001
        value
        113
      units
      Participants
    title
    Temperature: Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      266
    2. group Id
      OG001
      value
      117
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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)
  2. description
    Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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
    OG001
    title
    Recurrent or Metastatic Prostate Cancer (Cohort B)
param Type
MEAN
population Description
The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).
reporting Status
POSTED
time Frame
Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
title
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
type
SECONDARY
unit Of Measure
degrees Celsius

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Preserved source evidence · Not medical advice