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NCT04186845 · OUTCOME

Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence · Source last updated 2025-09-22

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

Measure
NUMBER
Unit
percentage
Interval / dispersion
95% Confidence Interval
Time frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

What was measured

Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients

Analysis population: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm, and with baseline PSA available

Groups in this outcome

PSA<0.5

PSA \< 0.5

0.5≤PSA<1.0

0.5 ≤ PSA \< 1.0

1.0≤PSA<2.0

1.0 ≤ PSA \< 2.0

2.0≤PSA<5.0

2.0 ≤ PSA \< 5.0

5.0≤PSA<10.0

5.0 ≤ PSA \< 10.0

PSA≥10.0

PSA ≥ 10.0

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<0.5105
0.5≤PSA<1.063
1.0≤PSA<2.043
2.0≤PSA<5.088
5.0≤PSA<10.036
PSA≥10.031

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PSA<0.529.5Not reported21.039.2Not reported
0.5≤PSA<1.044.4Not reported31.957.5Not reported
1.0≤PSA<2.065.1Not reported49.179.0Not reported
2.0≤PSA<5.072.7Not reported62.281.7Not reported
5.0≤PSA<10.061.1Not reported43.576.9Not reported
PSA≥10.080.7Not reported62.592.5Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PSA<0.523.8Not reported16.033.1Not reported
0.5≤PSA<1.041.3Not reported29.054.4Not reported
1.0≤PSA<2.065.1Not reported49.179.0Not reported
2.0≤PSA<5.070.5Not reported59.879.7Not reported
5.0≤PSA<10.058.3Not reported40.874.5Not reported
PSA≥10.083.9Not reported66.394.5Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PSA<0.525.7Not reported17.735.2Not reported
0.5≤PSA<1.046.0Not reported33.459.1Not reported
1.0≤PSA<2.062.8Not reported46.777.0Not reported
2.0≤PSA<5.069.3Not reported58.678.7Not reported
5.0≤PSA<10.058.3Not reported40.874.5Not reported
PSA≥10.077.4Not reported58.990.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.0
        upper Limit
        39.2
        value
        29.5
      2. group Id
        OG001
        lower Limit
        31.9
        upper Limit
        57.5
        value
        44.4
      3. group Id
        OG002
        lower Limit
        49.1
        upper Limit
        79.0
        value
        65.1
      4. group Id
        OG003
        lower Limit
        62.2
        upper Limit
        81.7
        value
        72.7
      5. group Id
        OG004
        lower Limit
        43.5
        upper Limit
        76.9
        value
        61.1
      6. group Id
        OG005
        lower Limit
        62.5
        upper Limit
        92.5
        value
        80.7
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.0
        upper Limit
        33.1
        value
        23.8
      2. group Id
        OG001
        lower Limit
        29.0
        upper Limit
        54.4
        value
        41.3
      3. group Id
        OG002
        lower Limit
        49.1
        upper Limit
        79.0
        value
        65.1
      4. group Id
        OG003
        lower Limit
        59.8
        upper Limit
        79.7
        value
        70.5
      5. group Id
        OG004
        lower Limit
        40.8
        upper Limit
        74.5
        value
        58.3
      6. group Id
        OG005
        lower Limit
        66.3
        upper Limit
        94.5
        value
        83.9
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.7
        upper Limit
        35.2
        value
        25.7
      2. group Id
        OG001
        lower Limit
        33.4
        upper Limit
        59.1
        value
        46.0
      3. group Id
        OG002
        lower Limit
        46.7
        upper Limit
        77.0
        value
        62.8
      4. group Id
        OG003
        lower Limit
        58.6
        upper Limit
        78.7
        value
        69.3
      5. group Id
        OG004
        lower Limit
        40.8
        upper Limit
        74.5
        value
        58.3
      6. group Id
        OG005
        lower Limit
        58.9
        upper Limit
        90.4
        value
        77.4
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      63
    3. group Id
      OG002
      value
      43
    4. group Id
      OG003
      value
      88
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      31
    units
    Participants
description
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients
dispersion Type
95% Confidence Interval
groups
  1. description
    PSA \< 0.5
    id
    OG000
    title
    PSA<0.5
  2. description
    0.5 ≤ PSA \< 1.0
    id
    OG001
    title
    0.5≤PSA<1.0
  3. description
    1.0 ≤ PSA \< 2.0
    id
    OG002
    title
    1.0≤PSA<2.0
  4. description
    2.0 ≤ PSA \< 5.0
    id
    OG003
    title
    2.0≤PSA<5.0
  5. description
    5.0 ≤ PSA \< 10.0
    id
    OG004
    title
    5.0≤PSA<10.0
  6. description
    PSA ≥ 10.0
    id
    OG005
    title
    PSA≥10.0
param Type
NUMBER
population Description
Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm, and with baseline PSA available
reporting Status
POSTED
time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
title
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
type
SECONDARY
unit Of Measure
percentage

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Preserved source evidence · Not medical advice