Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03511664 · OUTCOME

Duration of Time in Hospital Following 177Lu-PSMA-617 Administration

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
MEAN
Unit
Hours
Interval / dispersion
Standard Deviation
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 duration of time in hospital following 177Lu-PSMA-617 administration (hours) was the time span of patient discharged as captured on the 177Lu-PSMA-617 administration Case Report Form (CRF).

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)341
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone0

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)28.2546.578Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.578
        value
        28.25
denoms
  1. counts
    1. group Id
      OG000
      value
      341
    2. group Id
      OG001
      value
      0
    units
    Participants
description
The duration of time in hospital following 177Lu-PSMA-617 administration (hours) was the time span of patient discharged as captured on the 177Lu-PSMA-617 administration Case Report Form (CRF).
dispersion Type
Standard Deviation
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
MEAN
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
Duration of Time in Hospital Following 177Lu-PSMA-617 Administration
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice