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NCT03511664 · OUTCOME

Time to First Symptomatic Skeletal Event (SSE)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)

What was measured

Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit).

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)11.5Not reported10.313.2Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone6.8Not reported5.28.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.62
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Comment
    Two-sided stratified log-rank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.62
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Comment
    Two-sided stratified log-rank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.3
        upper Limit
        13.2
        value
        11.5
      2. group Id
        OG001
        lower Limit
        5.2
        upper Limit
        8.5
        value
        6.8
denoms
  1. counts
    1. group Id
      OG000
      value
      385
    2. group Id
      OG001
      value
      196
    units
    Participants
description
Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit).
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
MEDIAN
population Description
PFS Full Analysis Set (PFS-FAS)
reporting Status
POSTED
time Frame
From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
title
Time to First Symptomatic Skeletal Event (SSE)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice