NCT03511664 · OUTCOME

Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
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

PSA response was defined as the proportion of patients who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.

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

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 Percentage of participants · 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)	46.0	Not reported	40.9	51.1	Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone	7.1	Not reported	4.0	11.7	Not reported

Source statistical analyses

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

ci Lower Limit
6.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.0
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.001
param Type
Odds Ratio (OR)
param Value
11.19
statistical Comment
Two-sided Wald's Chi-square test (stratified)
statistical Method
Chi-squared

Complete source fields

analyses

ci Lower Limit
6.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.0
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.001
param Type
Odds Ratio (OR)
param Value
11.19
statistical Comment
Two-sided Wald's Chi-square test (stratified)
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
lower Limit
40.9
upper Limit
51.1
value
46.0
group Id
OG001
lower Limit
4.0
upper Limit
11.7
value
7.1

denoms

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

description

PSA response was defined as the proportion of patients who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.

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

NUMBER

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

Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice