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NCT03511664 · OUTCOME

Therapeutic Interventions for Health Economics Analysis

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 till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)

What was measured

The list of therapeutic interventions was pre-specified and flagged prior to the pre planned analyses as captured on: 1) the concurrent radiotherapy CRF page to include local external beam radiotherapy (inclusive of palliative external radiation), 2) on the concomitant medication/therapy CRF page to include blood transfusion (full blood or derivates).

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

Local external beam therapy

Yes

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)63Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone37Not reportedNot reportedNot reportedNot reported

No

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)322Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone159Not reportedNot reportedNot reportedNot reported
Blood transfusion

Yes

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)74Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone13Not reportedNot reportedNot reportedNot reported

No

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)311Not reportedNot reportedNot reportedNot reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone183Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        37
      title
      Yes
    2. measurements
      1. group Id
        OG000
        value
        322
      2. group Id
        OG001
        value
        159
      title
      No
    title
    Local external beam therapy
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        13
      title
      Yes
    2. measurements
      1. group Id
        OG000
        value
        311
      2. group Id
        OG001
        value
        183
      title
      No
    title
    Blood transfusion
denoms
  1. counts
    1. group Id
      OG000
      value
      385
    2. group Id
      OG001
      value
      196
    units
    Participants
description
The list of therapeutic interventions was pre-specified and flagged prior to the pre planned analyses as captured on: 1) the concurrent radiotherapy CRF page to include local external beam radiotherapy (inclusive of palliative external radiation), 2) on the concomitant medication/therapy CRF page to include blood transfusion (full blood or derivates).
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
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
Therapeutic Interventions for Health Economics Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice