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NCT03511664 · OUTCOME

Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Source last updated 2025-01-13

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

Measure
MEAN
Unit
Score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)

What was measured

The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The higher the EQ-VAS score, the better the QoL.

Analysis population: PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis.

Groups in this outcome

Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used

Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone

Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator

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

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)385
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone196

Reported measurements

Cycle 2, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)305
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone100
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)1.819.98Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-7.220.31Not reportedNot reportedNot reported
Cycle 3, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)272
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone53
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)1.419.82Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-3.821.50Not reportedNot reportedNot reported
Cycle 4, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)221
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone32
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)2.819.18Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-1.718.73Not reportedNot reportedNot reported
Cycle 5, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)180
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone21
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)4.017.30Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-8.528.88Not reportedNot reportedNot reported
Cycle 6, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)159
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone13
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)2.119.61Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone3.219.43Not reportedNot reportedNot reported
Cycle 7, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)121
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone11
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)3.620.64Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone5.912.79Not reportedNot reportedNot reported
Cycle 8, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)84
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone5
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)0.617.18Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone13.816.60Not reportedNot reportedNot reported
Cycle 9, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)54
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone6
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)0.119.68Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone6.320.82Not reportedNot reportedNot reported
Cycle 10, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)33
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)2.913.97Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-8.02.83Not reportedNot reportedNot reported
Cycle 11, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)12
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)5.810.33Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-9.028.28Not reportedNot reportedNot reported
Cycle 12, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)4
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)4.513.03Not reportedNot reportedNot reported
Cycle 13, Week 1, Day 1 change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)1
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)-5.0NANot reportedNot reportedNA: Only one participant analyzed
End of Treatment (EoT) change from BL

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)163
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone86
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)-8.922.07Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-10.121.49Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.98
        value
        1.8
      2. group Id
        OG001
        spread
        20.31
        value
        -7.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        305
      2. group Id
        OG001
        value
        100
      units
      Participants
    title
    Cycle 2, Week 1, Day 1 change from BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.82
        value
        1.4
      2. group Id
        OG001
        spread
        21.50
        value
        -3.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        272
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    Cycle 3, Week 1, Day 1 change from BL
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.18
        value
        2.8
      2. group Id
        OG001
        spread
        18.73
        value
        -1.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        221
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    Cycle 4, Week 1, Day 1 change from BL
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.30
        value
        4.0
      2. group Id
        OG001
        spread
        28.88
        value
        -8.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Cycle 5, Week 1, Day 1 change from BL
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.61
        value
        2.1
      2. group Id
        OG001
        spread
        19.43
        value
        3.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Cycle 6, Week 1, Day 1 change from BL
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.64
        value
        3.6
      2. group Id
        OG001
        spread
        12.79
        value
        5.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Cycle 7, Week 1, Day 1 change from BL
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.18
        value
        0.6
      2. group Id
        OG001
        spread
        16.60
        value
        13.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 8, Week 1, Day 1 change from BL
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.68
        value
        0.1
      2. group Id
        OG001
        spread
        20.82
        value
        6.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 9, Week 1, Day 1 change from BL
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.97
        value
        2.9
      2. group Id
        OG001
        spread
        2.83
        value
        -8.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Cycle 10, Week 1, Day 1 change from BL
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.33
        value
        5.8
      2. group Id
        OG001
        spread
        28.28
        value
        -9.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Cycle 11, Week 1, Day 1 change from BL
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.03
        value
        4.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Cycle 12, Week 1, Day 1 change from BL
  12. categories
    1. measurements
      1. comment
        NA: Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        -5.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Cycle 13, Week 1, Day 1 change from BL
denoms
  1. counts
    1. group Id
      OG000
      value
      385
    2. group Id
      OG001
      value
      196
    units
    Participants
description
The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The higher the EQ-VAS score, the better the QoL.
dispersion Type
Standard Deviation
groups
  1. description
    Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
    id
    OG000
    title
    Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  2. description
    Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
    id
    OG001
    title
    Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
param Type
MEAN
population Description
PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis.
reporting Status
POSTED
time Frame
Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)
title
Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS
type
SECONDARY
unit Of Measure
Score on a scale

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Preserved source evidence · Not medical advice