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NCT03511664 · OUTCOME

All Collected Deaths

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
Pre-treatment deaths: Up to 28 days prior to treatment. On-treatment deaths: Up to approximately 43 months. Post-treatment deaths: Up to approximately 66 months

What was measured

Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from first dose of study medication to 30 days after last dose of study medication (on-treatment), up to approximately 43 months. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approximately 66 months. These are not considered AEs

Analysis population: Full Analysis Set (FAS) and the participants included in the sub-study.

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

Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study

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)551
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone280
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)30

Reported measurements

Pre-treatment deaths

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)551
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone280
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)0Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0Not reportedNot reportedNot reportedNot reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)0Not reportedNot reportedNot reportedNot reported
On-treatment deaths

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)529
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone205
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)68Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone19Not reportedNot reportedNot reportedNot reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)5Not reportedNot reportedNot reportedNot reported
Post-treatment deaths

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)461
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone186
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)25
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)389Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone182Not reportedNot reportedNot reportedNot reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)16Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)551
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone280
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)457Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone201Not reportedNot reportedNot reportedNot reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        551
      2. group Id
        OG001
        value
        280
      3. group Id
        OG002
        value
        30
      units
      Participants
    title
    Pre-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        529
      2. group Id
        OG001
        value
        205
      3. group Id
        OG002
        value
        30
      units
      Participants
    title
    On-treatment deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        389
      2. group Id
        OG001
        value
        182
      3. group Id
        OG002
        value
        16
    denoms
    1. counts
      1. group Id
        OG000
        value
        461
      2. group Id
        OG001
        value
        186
      3. group Id
        OG002
        value
        25
      units
      Participants
    title
    Post-treatment deaths
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        457
      2. group Id
        OG001
        value
        201
      3. group Id
        OG002
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        551
      2. group Id
        OG001
        value
        280
      3. group Id
        OG002
        value
        30
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      551
    2. group Id
      OG001
      value
      280
    3. group Id
      OG002
      value
      30
    units
    Participants
description
Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from first dose of study medication to 30 days after last dose of study medication (on-treatment), up to approximately 43 months. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approximately 66 months. These are not considered AEs
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
  3. description
    non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study
    id
    OG002
    title
    Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS) and the participants included in the sub-study.
reporting Status
POSTED
time Frame
Pre-treatment deaths: Up to 28 days prior to treatment. On-treatment deaths: Up to approximately 43 months. Post-treatment deaths: Up to approximately 66 months
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice