NCT00295750 · STUDY IN CONTEXT

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.

Intent-to-treat (ITT) population.

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secondary · POSTED

A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).

ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.

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secondary · POSTED

This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.

ITT population.

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secondary · POSTED

Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252.

ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.

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secondary · POSTED

Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.

ITT population.

→

secondary · POSTED

The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.

ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer
nct id: NCT00295750
trial label: The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0000
source section id
NCT00295750-om-0000
source outcome index
0
endpoint
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
endpoint definition
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
time origin
12 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-treat (ITT) population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0001
source section id
NCT00295750-om-0001
source outcome index
1
endpoint
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
endpoint definition
A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).
time origin
2 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0002
source section id
NCT00295750-om-0002
source outcome index
2
endpoint
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
endpoint definition
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
time origin
3 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0003
source section id
NCT00295750-om-0003
source outcome index
3
endpoint
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
endpoint definition
Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252.
time origin
Day 252, Day 255, and Day 259
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0004
source section id
NCT00295750-om-0004
source outcome index
4
endpoint
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
endpoint definition
Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.
time origin
Days 14 and 28
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0005
source section id
NCT00295750-om-0005
source outcome index
5
endpoint
Participants Grouped by Time to Prostate-specific Antigen Failure
endpoint definition
The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.
time origin
12 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0000
arm key
OG000
arm label
Degarelix 240/160 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
analyzed count
202
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0000
arm key
OG001
arm label
Degarelix 240/80 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
analyzed count
207
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0000
arm key
OG002
arm label
Leuprolide 7.5 mg
regimen
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
analyzed count
201
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0001
arm key
OG000
arm label
Degarelix 240/160 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
analyzed count
202
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0001
arm key
OG001
arm label
Degarelix 240/80 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
analyzed count
207
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0001
arm key
OG002
arm label
Leuprolide 7.5 mg
regimen
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
analyzed count
201
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0002
arm key
OG000
arm label
Degarelix 240/160 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
analyzed count
202
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0002
arm key
OG001
arm label
Degarelix 240/80 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
analyzed count
207
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0002
arm key
OG002
arm label
Leuprolide 7.5 mg
regimen
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
analyzed count
201
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0003
arm key
OG000
arm label
Degarelix 240/160 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
analyzed count
176
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0003
arm key
OG001
arm label
Degarelix 240/80 mg
regimen
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
analyzed count
178
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
outcome key
om-0003
arm key
OG002
arm label
Leuprolide 7.5 mg
regimen
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
analyzed count
179
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00295750-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
harm key
EG000
source section id
NCT00295750-ae
event group key
EG000
event group label
Degarelix 240/160 mg
serious affected
Source null
serious at risk
Source null
other affected
Source null
other at risk
Source null
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
24 affected by a serious event, reported without a group denominator; 165 affected by a non-serious event, reported without a group denominator
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
harm key
EG001
source section id
NCT00295750-ae
event group key
EG001
event group label
Degarelix 240/80 mg
serious affected
Source null
serious at risk
Source null
other affected
Source null
other at risk
Source null
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
21 affected by a serious event, reported without a group denominator; 162 affected by a non-serious event, reported without a group denominator
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00295750
harm key
EG002
source section id
NCT00295750-ae
event group key
EG002
event group label
Leuprolide 7.5 mg
serious affected
Source null
serious at risk
Source null
other affected
Source null
other at risk
Source null
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
28 affected by a serious event, reported without a group denominator; 153 affected by a non-serious event, reported without a group denominator
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice