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NCT03511664 · OUTCOME

Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale

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 BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Interference items consist of scores from 0 ("Does Not Interfere") to 10 ("Completely Interferes"). BPI-SF Interference scale is the mean of non-missing items of the 7 items on pain interference, if there are 4 or more items not missing; otherwise this scale is set to missing.

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)311
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)-0.402.167Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.582.700Not 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)274
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone52
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)-0.352.348Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.152.216Not 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)223
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)-0.332.249Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.212.762Not 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)183
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)-0.322.223Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.523.480Not 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)161
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)-0.282.166Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.493.354Not 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)122
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)-0.221.882Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.062.570Not 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)86
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)0.181.926Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-0.261.291Not 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)55
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)-0.151.751Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.121.667Not 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)0.622.141Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone1.501.313Not 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)-0.061.334Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.364.748Not 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)-0.890.914Not 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)-0.43NANot 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)165
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone88
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)0.732.756Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.292.385Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.167
        value
        -0.40
      2. group Id
        OG001
        spread
        2.700
        value
        0.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        311
      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
        2.348
        value
        -0.35
      2. group Id
        OG001
        spread
        2.216
        value
        -0.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        274
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    Cycle 3, Week 1, Day 1 change from BL
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.249
        value
        -0.33
      2. group Id
        OG001
        spread
        2.762
        value
        0.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        223
      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
        2.223
        value
        -0.32
      2. group Id
        OG001
        spread
        3.480
        value
        0.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      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
        2.166
        value
        -0.28
      2. group Id
        OG001
        spread
        3.354
        value
        0.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      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
        1.882
        value
        -0.22
      2. group Id
        OG001
        spread
        2.570
        value
        0.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        122
      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
        1.926
        value
        0.18
      2. group Id
        OG001
        spread
        1.291
        value
        -0.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      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
        1.751
        value
        -0.15
      2. group Id
        OG001
        spread
        1.667
        value
        0.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      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
        2.141
        value
        0.62
      2. group Id
        OG001
        spread
        1.313
        value
        1.50
    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
        1.334
        value
        -0.06
      2. group Id
        OG001
        spread
        4.748
        value
        0.36
    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
        0.914
        value
        -0.89
    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
        -0.43
    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 BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Interference items consist of scores from 0 ("Does Not Interfere") to 10 ("Completely Interferes"). BPI-SF Interference scale is the mean of non-missing items of the 7 items on pain interference, if there are 4 or more items not missing; otherwise this scale is set to missing.
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 BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale
type
SECONDARY
unit Of Measure
Score on a scale

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Preserved source evidence · Not medical advice