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NCT03511664 · OUTCOME

Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total 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 FACT-P total score (range 0-156) consist of five subscales (Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24)) and a functional well-being and prostate cancer subscale (range 0-48). Higher scores indicate higher degree of functioning and better quality of life.

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)3.616.63Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-7.217.85Not 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)269
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)3.817.48Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-2.614.00Not 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)222
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)5.415.93Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-1.318.40Not 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)181
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)4.016.24Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-5.927.83Not 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)158
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)4.115.22Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-5.026.87Not 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)4.916.47Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-2.917.89Not 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)3.815.87Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-13.032.76Not 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)3.814.22Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone6.95.92Not 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)0.018.27Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0.214.14Not 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)-0.820.99Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone8.233.71Not 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)10.312.11Not 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)30.0NANot 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)161
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)-9.421.64Not reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone-10.418.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.63
        value
        3.6
      2. group Id
        OG001
        spread
        17.85
        value
        -7.2
    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
        17.48
        value
        3.8
      2. group Id
        OG001
        spread
        14.00
        value
        -2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        269
      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
        15.93
        value
        5.4
      2. group Id
        OG001
        spread
        18.40
        value
        -1.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        222
      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
        16.24
        value
        4.0
      2. group Id
        OG001
        spread
        27.83
        value
        -5.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      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
        15.22
        value
        4.1
      2. group Id
        OG001
        spread
        26.87
        value
        -5.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        158
      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
        16.47
        value
        4.9
      2. group Id
        OG001
        spread
        17.89
        value
        -2.9
    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
        15.87
        value
        3.8
      2. group Id
        OG001
        spread
        32.76
        value
        -13.0
    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
        14.22
        value
        3.8
      2. group Id
        OG001
        spread
        5.92
        value
        6.9
    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
        18.27
        value
        0.0
      2. group Id
        OG001
        spread
        14.14
        value
        0.2
    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
        20.99
        value
        -0.8
      2. group Id
        OG001
        spread
        33.71
        value
        8.2
    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
        12.11
        value
        10.3
    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
        30.0
    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 FACT-P total score (range 0-156) consist of five subscales (Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24)) and a functional well-being and prostate cancer subscale (range 0-48). Higher scores indicate higher degree of functioning and better quality of life.
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 FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice