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NCT04186845 · OUTCOME

Region-level PPV 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

Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify 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.

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 <0.529.1Not reported20.537.7Not reported
0.5≤PSA<1.037.1Not reported27.646.6Not reported
1.0≤PSA<2.045.6Not reported35.156.1Not reported
2.0≤PSA<5.057.7Not reported50.165.3Not reported
5.0≤PSA<10.057.9Not reported44.970.9Not reported
PSA≥10.059.6Not reported47.671.7Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PSA <0.550.8Not reported36.964.8Not reported
0.5≤PSA<1.051.8Not reported38.964.6Not reported
1.0≤PSA<2.057.4Not reported43.771.1Not reported
2.0≤PSA<5.065.0Not reported55.374.6Not reported
5.0≤PSA<10.071.7Not reported56.886.7Not reported
PSA≥10.062.7Not reported50.674.9Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PSA <0.534.5Not reported24.045.0Not reported
0.5≤PSA<1.045.1Not reported33.556.7Not reported
1.0≤PSA<2.052.5Not reported38.766.2Not reported
2.0≤PSA<5.064.9Not reported55.973.9Not reported
5.0≤PSA<10.058.7Not reported41.575.9Not reported
PSA≥10.060.8Not reported47.374.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.5
        upper Limit
        37.7
        value
        29.1
      2. group Id
        OG001
        lower Limit
        27.6
        upper Limit
        46.6
        value
        37.1
      3. group Id
        OG002
        lower Limit
        35.1
        upper Limit
        56.1
        value
        45.6
      4. group Id
        OG003
        lower Limit
        50.1
        upper Limit
        65.3
        value
        57.7
      5. group Id
        OG004
        lower Limit
        44.9
        upper Limit
        70.9
        value
        57.9
      6. group Id
        OG005
        lower Limit
        47.6
        upper Limit
        71.7
        value
        59.6
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.9
        upper Limit
        64.8
        value
        50.8
      2. group Id
        OG001
        lower Limit
        38.9
        upper Limit
        64.6
        value
        51.8
      3. group Id
        OG002
        lower Limit
        43.7
        upper Limit
        71.1
        value
        57.4
      4. group Id
        OG003
        lower Limit
        55.3
        upper Limit
        74.6
        value
        65.0
      5. group Id
        OG004
        lower Limit
        56.8
        upper Limit
        86.7
        value
        71.7
      6. group Id
        OG005
        lower Limit
        50.6
        upper Limit
        74.9
        value
        62.7
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.0
        upper Limit
        45.0
        value
        34.5
      2. group Id
        OG001
        lower Limit
        33.5
        upper Limit
        56.7
        value
        45.1
      3. group Id
        OG002
        lower Limit
        38.7
        upper Limit
        66.2
        value
        52.5
      4. group Id
        OG003
        lower Limit
        55.9
        upper Limit
        73.9
        value
        64.9
      5. group Id
        OG004
        lower Limit
        41.5
        upper Limit
        75.9
        value
        58.7
      6. group Id
        OG005
        lower Limit
        47.3
        upper Limit
        74.2
        value
        60.8
    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
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify 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.
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
Region-level PPV 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