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NCT02981368 · OUTCOME

Mean Change From Baseline in Heart Rate 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
beats per minute
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)268
Recurrent or Metastatic Prostate Cancer (Cohort B)117

Reported measurements

Heart Rate: Baseline (Actual)

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)268
Recurrent or Metastatic Prostate Cancer (Cohort B)117
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)70.712.03Not reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B)71.312.94Not reportedNot reportedNot reported
Heart Rate: Post-dosing (Actual)

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)265
Recurrent or Metastatic Prostate Cancer (Cohort B)114
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)66.410.98Not reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B)67.011.23Not reportedNot reportedNot reported
Heart Rate: Change from Baseline

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A)265
Recurrent or Metastatic Prostate Cancer (Cohort B)114
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A)-4.46.88Not reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B)-4.66.53Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.03
        value
        70.7
      2. group Id
        OG001
        spread
        12.94
        value
        71.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        268
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Heart Rate: Baseline (Actual)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.98
        value
        66.4
      2. group Id
        OG001
        spread
        11.23
        value
        67.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        114
      units
      Participants
    title
    Heart Rate: Post-dosing (Actual)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.88
        value
        -4.4
      2. group Id
        OG001
        spread
        6.53
        value
        -4.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        114
      units
      Participants
    title
    Heart Rate: Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    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 Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
type
SECONDARY
unit Of Measure
beats per minute

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

Preserved source evidence · Not medical advice