Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

NCTNCT00831233Other idFE200486 CS28Other id2008-004338-26Other id2008

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Poor recruitment due to rare targeted population

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 42 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 3 countries
Germany, Spain, United Kingdom
Start: Apr 2009
Primary completion: Jun 2010
Completion: Jul 2010
First posted: 28 Jan 2009 (estimated)
Last update posted: 11 Nov 2013 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 3
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT00831233
Apr 2009 to Jul 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Interventions

DegarelixDrug
GoserelinDrug
BicalutamideDrug

Arms2

Experimental
Degarelix 240 mg/80 mg
Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
Active comparator
Goserelin (3.6 mg) + bicalutamide (50 mg)
Goserelin (3.6 mg) + bicalutamide (50 mg)

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
Time frame · After treatment of 12 weeks compared to Baseline
Registry description
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 outcomes(9)

Change From Baseline in Total IPSS at Weeks 4 and 8
Time frame · After treatment of 4 and 8 weeks compared to Baseline
Registry description
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.
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit
Time frame · After treatment of 4, 8 and 12 weeks compared to Baseline
Registry description
Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)
Change From Baseline in Residual Volume (Vresidual) at Each Visit
Time frame · After treatment of 4, 8 and 12 weeks compared to Baseline
Registry description
Uroflowmetry was used to quantify the residual volume (Vresidual; mL)
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12
Time frame · After 12 weeks treatment compared to Baseline
Registry description
TRUS is a method of measuring the size of the prostate.
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit
Time frame · After treatment of 4, 8 and 12 weeks compared to Baseline
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit
Time frame · After treatment of 4, 8 and 12 weeks compared to Baseline
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
Time frame · After treatment of 4, 8 and 12 weeks compared to Baseline
Registry description
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.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame · Baseline to 12 weeks of treatment
Registry description
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.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame · Baseline to 12 weeks of treatment
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· After treatment of 12 weeks compared to Baseline

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12

Group	Value (score on scale)	Spread
Degarelix 240 mg/80 mg	-11.2	8.29
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-7.69	7.61

Secondary and other outcome results(7)

Secondary outcomeMean· After treatment of 4 and 8 weeks compared to Baseline

Change From Baseline in Total IPSS at Weeks 4 and 8

Group	Value (score on scale)	Spread
Degarelix 240 mg/80 mg	-7.31	5.83
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-4.62	5.49

Secondary outcomeMean· After treatment of 4, 8 and 12 weeks compared to Baseline

Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit

Group	Value (mL/sec)	Spread
Degarelix 240 mg/80 mg	3.63	7.82
Goserelin (3.6 mg) + Bicalutamide (50 mg)	3.55	3.80

Secondary outcomeMean· After treatment of 4, 8 and 12 weeks compared to Baseline

Change From Baseline in Residual Volume (Vresidual) at Each Visit

Group	Value (mL)	Spread
Degarelix 240 mg/80 mg	-36.2	148
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-19.8	63.5

Secondary outcomeMean· After 12 weeks treatment compared to Baseline

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12

Group	Value (mL)	Spread
Degarelix 240 mg/80 mg	-22.4	14.8
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-13.4	10.0

Secondary outcomeNumber· After treatment of 4, 8 and 12 weeks compared to Baseline

Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit

Group	Value (participants)
Degarelix 240 mg/80 mg	26
Goserelin (3.6 mg) + Bicalutamide (50 mg)	12

Secondary outcomeMedian· After treatment of 4, 8 and 12 weeks compared to Baseline

Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit

Group	Value (percentage)
Degarelix 240 mg/80 mg	-85.72
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-93.44

Secondary outcomeMean· After treatment of 4, 8 and 12 weeks compared to Baseline

Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit

Group	Value (score on scale)	Spread
Degarelix 240 mg/80 mg	-0.96	0.92
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-0.54	1.51

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 240 mg/80 mgDegarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	–	0 / 27	14 / 27
Goserelin (3.6 mg) + Bicalutamide (50 mg)Goserelin (3.6 mg) + bicalutamide (50 mg)	–	1 / 13	7 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

6 results

Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233).

Anderson et al. 2013Urologia internationaliscited by 42

PMID 23258223DOI 10.1159/000345423PUB-23258223

Full text at the publisher6 results

Publisher page See results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Patient has given written informed consent before any trial-related activity is performed * Has a confirmed prostate cancer in which this type of treatment is needed. Exclusion Criteria: * Previous treatment for prostate cancer * Previous trans-urethral resection of the prostate * Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist. * Patients in need of external beam radiotherapy to be started at the same time as hormone therapy * Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk) * History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Hypersensitivity towards any component of the investigational product * Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer. * Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

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