Trial · NCT00831233

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

NCT00831233, Phase 3, Terminated, Ferring Pharmaceuticals; results first posted 2011-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer. Trials, record NCT00831233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00831233

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT number: NCT00831233
Status: Terminated
Phases: Phase 3
Enrollment: 42 participants, actual
Lead sponsor: Ferring Pharmaceuticals
Conditions: Prostate Cancer
Interventions: Degarelix, Goserelin, Bicalutamide
First posted: 2009-01-28
Last updated: 2013-11-11
Other registries' IDs: eudract:2008-004338-26
Results first posted: 2011-08-26
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	After treatment of 12 weeks compared to Baseline	The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Secondary	Change From Baseline in Total IPSS at Weeks 4 and 8	After treatment of 4 and 8 weeks compared to Baseline	The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Secondary	Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)
Secondary	Change From Baseline in Residual Volume (Vresidual) at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	Uroflowmetry was used to quantify the residual volume (Vresidual; mL)
Secondary	Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12	After 12 weeks treatment compared to Baseline	TRUS is a method of measuring the size of the prostate.
Secondary	Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline
Secondary	Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline
Secondary	Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.
Secondary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	Baseline to 12 weeks of treatment	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Secondary	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	Baseline to 12 weeks of treatment	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	After treatment of 12 weeks compared to Baseline	Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).	score on scale	MEAN
SECONDARY	Change From Baseline in Total IPSS at Weeks 4 and 8	After treatment of 4 and 8 weeks compared to Baseline	FAS, LOCF.	score on scale	MEAN
SECONDARY	Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	FAS, LOCF.	mL/sec	MEAN
SECONDARY	Change From Baseline in Residual Volume (Vresidual) at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	FAS, LOCF.	mL	MEAN
SECONDARY	Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12	After 12 weeks treatment compared to Baseline	FAS, Observed Cases (OC).	mL	MEAN
SECONDARY	Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	FAS, OC.	participants	NUMBER
SECONDARY	Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	FAS, LOCF.	percentage	MEDIAN
SECONDARY	Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit	After treatment of 4, 8 and 12 weeks compared to Baseline	FAS, OC.	score on scale	MEAN
SECONDARY	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	Baseline to 12 weeks of treatment	FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).	participants	NUMBER
SECONDARY	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	Baseline to 12 weeks of treatment	FAS.	participants	NUMBER

Source ClinicalTrials.gov

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	Degarelix 240 mg/80 mg		-11.2	Standard Deviation 8.29	score on scale
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	Goserelin (3.6 mg) + Bicalutamide (50 mg)		-7.69	Standard Deviation 7.61	score on scale
Change From Baseline in Total IPSS at Weeks 4 and 8	Degarelix 240 mg/80 mg	Week 4	-7.31	Standard Deviation 5.83	score on scale
Change From Baseline in Total IPSS at Weeks 4 and 8	Goserelin (3.6 mg) + Bicalutamide (50 mg)	Week 4	-4.62	Standard Deviation 5.49	score on scale
Change From Baseline in Total IPSS at Weeks 4 and 8	Degarelix 240 mg/80 mg	Week 8	-9.46	Standard Deviation 6.94	score on scale
Change From Baseline in Total IPSS at Weeks 4 and 8	Goserelin (3.6 mg) + Bicalutamide (50 mg)	Week 8	-8.08	Standard Deviation 9.00	score on scale
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	Degarelix 240 mg/80 mg	Week 4	3.63	Standard Deviation 7.82	mL/sec
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	Goserelin (3.6 mg) + Bicalutamide (50 mg)	Week 4	3.55	Standard Deviation 3.80	mL/sec
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	Degarelix 240 mg/80 mg	Week 8	4.74	Standard Deviation 6.60	mL/sec
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	Goserelin (3.6 mg) + Bicalutamide (50 mg)	Week 8	3.52	Standard Deviation 3.58	mL/sec

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Degarelix 240 mg/80 mg	29
Overall Study	STARTED	Goserelin (3.6 mg) + Bicalutamide (50 mg)	13
Overall Study	Full Analysis Set (FAS)	Degarelix 240 mg/80 mg	27
Overall Study	Full Analysis Set (FAS)	Goserelin (3.6 mg) + Bicalutamide (50 mg)	13
Overall Study	Per Protocol (PP) Analysis Set	Degarelix 240 mg/80 mg	26
Overall Study	Per Protocol (PP) Analysis Set	Goserelin (3.6 mg) + Bicalutamide (50 mg)	11
Overall Study	COMPLETED	Degarelix 240 mg/80 mg	26
Overall Study	COMPLETED	Goserelin (3.6 mg) + Bicalutamide (50 mg)	12
Overall Study	NOT COMPLETED	Degarelix 240 mg/80 mg	3
Overall Study	NOT COMPLETED	Goserelin (3.6 mg) + Bicalutamide (50 mg)	1

Source ClinicalTrials.gov

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Degarelix 240 mg/80 mg	2	27	2
other	Anaemia	Blood and lymphatic system disorders	Goserelin (3.6 mg) + Bicalutamide (50 mg)	0	13	0
other	Leukocytosis	Blood and lymphatic system disorders	Degarelix 240 mg/80 mg	0	27	0
other	Leukocytosis	Blood and lymphatic system disorders	Goserelin (3.6 mg) + Bicalutamide (50 mg)	1	13	1
other	Reproductive tract hypoplasia, male	Congenital, familial and genetic disorders	Degarelix 240 mg/80 mg	2	27	2
other	Reproductive tract hypoplasia, male	Congenital, familial and genetic disorders	Goserelin (3.6 mg) + Bicalutamide (50 mg)	0	13	0
other	Constipation	Gastrointestinal disorders	Degarelix 240 mg/80 mg	3	27	3
other	Constipation	Gastrointestinal disorders	Goserelin (3.6 mg) + Bicalutamide (50 mg)	0	13	0
other	Injection site pain	General disorders	Degarelix 240 mg/80 mg	6	27	16
other	Injection site pain	General disorders	Goserelin (3.6 mg) + Bicalutamide (50 mg)	0	13	0

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Degarelix 240 mg/80 mg
Total, all-cause mortality	Goserelin (3.6 mg) + Bicalutamide (50 mg)
Total, other adverse events	Degarelix 240 mg/80 mg	14	27
Total, other adverse events	Goserelin (3.6 mg) + Bicalutamide (50 mg)	7	13
Total, serious adverse events	Degarelix 240 mg/80 mg	0	27
Total, serious adverse events	Goserelin (3.6 mg) + Bicalutamide (50 mg)	1	13

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23258223	RESULT	PubMed
34350976	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Degarelix 240 mg/80 mg vs Goserelin (3.6 mg) + Bicalutamide (50 mg): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00831233

GET https://conductscience.org/api/trials/v1/NCT00831233/results?page=2

API reference For AI assistants