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NCT03511664 · OUTCOME

Overall Response Rate (ORR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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

Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with evaluable disease at baseline per central review assessment.

Analysis population: Response Evaluable Analysis Set

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)319
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone120

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)95Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    6.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    103.24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    param Type
    Odds Ratio (OR)
    param Value
    24.99
    statistical Comment
    Two-sided Wald's Chi-square test (stratified)
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    6.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    103.24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.001
    param Type
    Odds Ratio (OR)
    param Value
    24.99
    statistical Comment
    Two-sided Wald's Chi-square test (stratified)
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      319
    2. group Id
      OG001
      value
      120
    units
    Participants
description
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with evaluable disease at baseline per central review assessment.
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
COUNT_OF_PARTICIPANTS
population Description
Response Evaluable Analysis Set
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
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice