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NCT03511664 · OUTCOME

Prostate-specific Antigen 80 (PSA80) Response

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)

What was measured

PSA80 response was defined as the proportion of participants who had a \>= 80% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.

Analysis population: PFS Full Analysis Set (PFS-FAS)

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

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)33.0Not reported28.337.9Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone2.0Not reported0.65.1Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    8.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    65.1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    param Type
    Odds Ratio (OR)
    param Value
    23.6
    statistical Comment
    Two-sided Wald's Chi-square test (stratified)
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    8.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    65.1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    param Type
    Odds Ratio (OR)
    param Value
    23.6
    statistical Comment
    Two-sided Wald's Chi-square test (stratified)
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.3
        upper Limit
        37.9
        value
        33.0
      2. group Id
        OG001
        lower Limit
        0.6
        upper Limit
        5.1
        value
        2.0
denoms
  1. counts
    1. group Id
      OG000
      value
      385
    2. group Id
      OG001
      value
      196
    units
    Participants
description
PSA80 response was defined as the proportion of participants who had a \>= 80% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
PFS Full Analysis Set (PFS-FAS)
reporting Status
POSTED
time Frame
From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
title
Prostate-specific Antigen 80 (PSA80) Response
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice