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NCT02918357 · OUTCOME

Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence · Source last updated 2019-12-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage detected
Interval / dispersion
Not reported
Time frame
1 month

What was measured

Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-\<0.5; 0.5-\<1.0; 1.0-\<2.0; 2.0-\<5.0, and ≥5.0).

Analysis population: Portion of patients with 68Ga-PSMA-11 PET positive findings were stratified by PSA range and disease location in accordance with Prostate Magnetic Resonance Imaging Study (PROMIS)

Groups in this outcome

PSA <0.5

Patients whom have a PSA nadir value of \<0.5

PSA 0.5 - <1.0

Patients whom have a PSA nadir value of 0.5 to \<1.0

PSA 1.0 - <2.0

Patients whom have a PSA nadir value of 1.0 to \<2.0

PSA 2.0 - <5.0

Patients whom have a PSA nadir value of 2.0 - \<5.0

PSA ≥5.0

Patients whom have a PSA nadir value of ≥5.0

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

Analysis denominator · Participants

GroupSource count
PSA <0.582
PSA 0.5 - <1.041
PSA 1.0 - <2.053
PSA 2.0 - <5.0103
PSA ≥5.0106

Reported measurements

Source class 1
Values in percentage detected · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PSA <0.540Not reportedNot reportedNot reportedNot reported
PSA 0.5 - <1.051Not reportedNot reportedNot reportedNot reported
PSA 1.0 - <2.087Not reportedNot reportedNot reportedNot reported
PSA 2.0 - <5.083Not reportedNot reportedNot reportedNot reported
PSA ≥5.096Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        87
      4. group Id
        OG003
        value
        83
      5. group Id
        OG004
        value
        96
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      41
    3. group Id
      OG002
      value
      53
    4. group Id
      OG003
      value
      103
    5. group Id
      OG004
      value
      106
    units
    Participants
description
Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-\<0.5; 0.5-\<1.0; 1.0-\<2.0; 2.0-\<5.0, and ≥5.0).
groups
  1. description
    Patients whom have a PSA nadir value of \<0.5
    id
    OG000
    title
    PSA <0.5
  2. description
    Patients whom have a PSA nadir value of 0.5 to \<1.0
    id
    OG001
    title
    PSA 0.5 - <1.0
  3. description
    Patients whom have a PSA nadir value of 1.0 to \<2.0
    id
    OG002
    title
    PSA 1.0 - <2.0
  4. description
    Patients whom have a PSA nadir value of 2.0 - \<5.0
    id
    OG003
    title
    PSA 2.0 - <5.0
  5. description
    Patients whom have a PSA nadir value of ≥5.0
    id
    OG004
    title
    PSA ≥5.0
param Type
NUMBER
population Description
Portion of patients with 68Ga-PSMA-11 PET positive findings were stratified by PSA range and disease location in accordance with Prostate Magnetic Resonance Imaging Study (PROMIS)
reporting Status
POSTED
time Frame
1 month
title
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
type
SECONDARY
unit Of Measure
percentage detected

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Preserved source evidence · Not medical advice