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NCT03511664 · OUTCOME

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

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-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales. The weights were based on value sets which were country-specific for the U.K. Utility scores ranges from the lowest possible score for a living patient of -0.594 (when all responses are '5') to 1 (when all responses are '1').If a patient died, he was assigned a score of 0 on the date of death.

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)304
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)0.02210.17693Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.08970.24973Not 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)273
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)0.02970.18817Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.03310.14155Not 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)0.02920.17713Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.08180.23752Not 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)0.03980.16827Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.06730.28633Not 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)0.03420.17950Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.01100.17842Not 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)0.02520.16127Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.00880.09081Not 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)0.02850.18017Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.02960.14964Not 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)0.01000.17447Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.00870.08167Not 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)0.01340.15764Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.06550.09263Not 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)0.04640.16858Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.02500.19940Not 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)0.11180.13833Not 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)0.0640NANot 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) Alone85
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)-0.09390.22698Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.09000.21223Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.17693
        value
        0.0221
      2. group Id
        OG001
        spread
        0.24973
        value
        -0.0897
    denoms
    1. counts
      1. group Id
        OG000
        value
        304
      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
        0.18817
        value
        0.0297
      2. group Id
        OG001
        spread
        0.14155
        value
        -0.0331
    denoms
    1. counts
      1. group Id
        OG000
        value
        273
      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
        0.17713
        value
        0.0292
      2. group Id
        OG001
        spread
        0.23752
        value
        -0.0818
    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
        0.16827
        value
        0.0398
      2. group Id
        OG001
        spread
        0.28633
        value
        -0.0673
    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
        0.17950
        value
        0.0342
      2. group Id
        OG001
        spread
        0.17842
        value
        -0.0110
    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
        0.16127
        value
        0.0252
      2. group Id
        OG001
        spread
        0.09081
        value
        -0.0088
    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
        0.18017
        value
        0.0285
      2. group Id
        OG001
        spread
        0.14964
        value
        -0.0296
    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
        0.17447
        value
        0.0100
      2. group Id
        OG001
        spread
        0.08167
        value
        0.0087
    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
        0.15764
        value
        0.0134
      2. group Id
        OG001
        spread
        0.09263
        value
        -0.0655
    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
        0.16858
        value
        0.0464
      2. group Id
        OG001
        spread
        0.19940
        value
        0.0250
    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
        0.13833
        value
        0.1118
    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
        0.0640
    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-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales. The weights were based on value sets which were country-specific for the U.K. Utility scores ranges from the lowest possible score for a living patient of -0.594 (when all responses are '5') to 1 (when all responses are '1').If a patient died, he was assigned a score of 0 on the date of death.
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) Utility Score
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice