NCT03511664 · OUTCOME

Time to Worsening in FACT-P Total Score

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)

What was measured

Time to worsening was defined as the time from randomization to the first occurring of a \>=10 point decrease in FACT-P total score compared to baseline, clinical disease progression, or death.

Analysis population: PFS-Full 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

Group	Source 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) Alone	196

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)	5.7	Not reported	4.8	6.6	Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone	2.2	Not reported	1.8	2.8	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
4.8
upper Limit
6.6
value
5.7
group Id
OG001
lower Limit
1.8
upper Limit
2.8
value
2.2

denoms

counts
group Id
OG000
value
385
group Id
OG001
value
196
units
Participants

description

Time to worsening was defined as the time from randomization to the first occurring of a \>=10 point decrease in FACT-P total score compared to baseline, clinical disease progression, or death.

dispersion Type

95% Confidence Interval

groups

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)
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

MEDIAN

population Description

PFS-Full analysis set

reporting Status

POSTED

time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)

title

Time to Worsening in FACT-P Total Score

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice