Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04689828 · OUTCOME

Overall Survival (OS) (Key Secondary Endpoint)

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer · Source last updated 2026-08-26

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
approx. 26.9 months from randomization to cut-off

What was measured

OS is defined as time to death for any cause.

Analysis population: FAS comprised all participants to whom study treatment was assigned by randomization.

Groups in this outcome

177Lu-PSMA-617 (AAA617)

Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.

Androgen Receptor-directed Therapy (ARDT)

For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
177Lu-PSMA-617 (AAA617)234
Androgen Receptor-directed Therapy (ARDT)234

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-PSMA-617 (AAA617)24.48Not reported19.5528.94Not reported
Androgen Receptor-directed Therapy (ARDT)23.13Not reported19.6125.53Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.20
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    stratified Cox PH model
Complete source fields
analyses
  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.20
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    stratified Cox PH model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.55
        upper Limit
        28.94
        value
        24.48
      2. group Id
        OG001
        lower Limit
        19.61
        upper Limit
        25.53
        value
        23.13
denoms
  1. counts
    1. group Id
      OG000
      value
      234
    2. group Id
      OG001
      value
      234
    units
    Participants
description
OS is defined as time to death for any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
    id
    OG000
    title
    177Lu-PSMA-617 (AAA617)
  2. description
    For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
    id
    OG001
    title
    Androgen Receptor-directed Therapy (ARDT)
param Type
MEDIAN
population Description
FAS comprised all participants to whom study treatment was assigned by randomization.
reporting Status
POSTED
time Frame
approx. 26.9 months from randomization to cut-off
title
Overall Survival (OS) (Key Secondary Endpoint)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice