Trial · Interventional

CompletedPhase 3Results postedRegistry data

Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

NCTNCT00884273Other idFE200486 CS31Other id2008-008604-40Other id2008

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 182 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 8 countries
Belgium, Denmark, Finland, Italy, Norway, Portugal, Sweden, Turkey (Türkiye)
Start: Aug 2009
Primary completion: Mar 2011
Completion: Mar 2011
First posted: 20 Apr 2009 (estimated)
Last update posted: 13 Nov 2013 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

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

2009201020112012

Ph 3
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
NCT00884273
Aug 2009 to Mar 2011

Registry summary

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

This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

Interventions

DegarelixDrug
GoserelinDrug
BicalutamideDrug

Arms2

Experimental
Degarelix 240 mg/80 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Active comparator
Goserelin (3.6 mg) + bicalutamide (50 mg)
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.

Primary outcomes2

Outcomes the sponsor listed as primary.

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Time frame · After treatment of 12 weeks compared to Baseline
Registry description
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
Time frame · After treatment of 12 weeks compared to Baseline
Registry description
TRUS is a method of measuring the size of the prostate.

Secondary outcomes(8)

Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
Time frame · After treatment of 4 and 8 weeks compared to Baseline
Registry description
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
Time frame · After treatment of 4, 8, and 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.
Change in Serum Testosterone Levels During the Study
Time frame · At 4, 8, and 12 weeks compared to baseline.
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time frame · At 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').
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
Time frame · After treatment of 4, 8, and 12 weeks compared to Baseline
Registry description
The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.
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 one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

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 Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)

Group	Value (milliliter)	Spread
Degarelix 240 mg/80 mg	-37.2	16.8
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-39.0	17.7

Secondary and other outcome results(7)

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

Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8

Group	Value (milliliter)	Spread
Degarelix 240 mg/80 mg	-19.2	15.2
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-21.2	17.7

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

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12

Group	Value (scores on a scale)	Spread
Degarelix 240 mg/80 mg	-2.09	4.36
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-1.36	5.86

Secondary outcomeMedian· At 4, 8, and 12 weeks compared to baseline.

Change in Serum Testosterone Levels During the Study

Group	Value (nanograms per milliliter)
Degarelix 240 mg/80 mg	-3.91
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-4.17

Secondary outcomeMedian· At 4, 8, and 12 weeks compared to baseline.

Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study

Group	Value (nanograms per milliliter)
Degarelix 240 mg/80 mg	-20.25
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-12.10

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 (scores on a scale)	Spread
Degarelix 240 mg/80 mg	-0.46	1.43
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-0.56	1.30

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

Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)

Group	Value (scores on a scale)	Spread
Degarelix 240 mg/80 mg	-0.78	2.03
Goserelin (3.6 mg) + Bicalutamide (50 mg)	-0.70	2.34

Secondary outcomeNumber· Baseline to 12 weeks of treatment

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Group	Value (participants)
Degarelix 240 mg/80 mg	0
Goserelin (3.6 mg) + Bicalutamide (50 mg)	0

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 mgThe degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.	–	1 / 84	33 / 84
Goserelin (3.6 mg) + Bicalutamide (50 mg)Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.	–	7 / 98	47 / 98

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 · 2012

4 results

Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide.

Axcrona et al. 2012BJU internationalcited by 81

PMID 22500884DOI 10.1111/j.1464-410x.2012.11107.xPUB-22500884

Rights unknown4 results

Source link See results (4)

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: 1. Patient has given written informed consent 2. Patient is 18 years or older 3. Patient has histologically confirmed prostate cancer 4. Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL 5. The prostate size is \>30 cubic centimetres (cc), measured by TRUS 6. Patient has had a bone-scan within 12 weeks before inclusion 7. Patient must be able to undergo transrectal examinations 8. Patient has an estimated life expectancy of at least 12 months Exclusion Criteria: 1. Any previous treatments for prostate cancer 2. Previous trans-urethral resection of the prostate (TURP) 3. Is not considered a candidate for medical castration 4. Use of urethral catheter 5. Is currently treated with a 5-alpha reductase inhibitor 6. Is currently treated with an alpha-adrenoceptor antagonist 7. Treatment with botulinum toxin A (Botox) 8. Require radiotherapy during the trial 9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema 10. Hypersensitivity towards any component of the investigational products or excipients 11. Previous history or presence of another malignancy 12. A clinically significant disorder 13. A corrected QT interval over 450 msec 14. Mental incapacity or language barrier precluding adequate understanding or co-operation 15. Receipt of an investigational drug within the last 28 days proceeding screening 16. Previous participation in any degarelix trial

PepBank is a research reference. Talk to a doctor before you use any peptide.