Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

NCTNCT00116753Other idFE200486 CS15

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 460 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 11 countries
United States, Belgium, Canada, Finland, France, Germany, Netherlands, Romania, Russia, Serbia and Montenegro, United Kingdom
Start: Jan 2005
Primary completion: Nov 2006
Completion: Nov 2006
First posted: 1 Jul 2005 (estimated)
Last update posted: 10 Dec 2010 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

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

200520062007

Ph 2
A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
NCT00116753
Jan 2005 to Nov 2006

Registry summary

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

The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

Interventions

DegarelixDrug
DegarelixDrug
DegarelixDrug

Arms3

Active comparator
Degarelix 240@40/240@40 (1,3,6,9)
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
Active comparator
Degarelix 240@40/240@60(1,3,6,9)
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
Active comparator
Degarelix 240@40/240@60(1,4,7,10)
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
Time frame · From Day 28 to 12 or 13 months
Registry description
Figure in the table give the number of participants with all testosterone values \<=0.5 ng/mL from Day 28 to the end of the study.

Secondary outcomes(4)

Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study
Time frame · From after Day 28 to 12 or 13 months
Registry description
Figures in the table give the number of participants with all testosterone values \<=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.
Number of Participants With Testosterone <=0.5 ng/mL at Day 28
Time frame · 28 Days
Registry description
Figures in the table give number of participants with testosterone \<=0.5 ng/mL 28 days after the initial dose of trial medication.
Liver Function Tests
Time frame · 12 or 13 months
Registry description
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline
Time frame · 12 or 13 months
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.

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 outcomeNumber· From Day 28 to 12 or 13 months

Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study

Group	Value (participants)
Degarelix 240@40/240@40 (1,3,6,9)	94
Degarelix 240@40/240@60 (1,3,6,9)	101
Degarelix 240@40/240@60 (1,4,7,10)	110

Secondary and other outcome results(4)

Secondary outcomeNumber· From after Day 28 to 12 or 13 months

Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study

Group	Value (participants)
Degarelix 240@40/240@40 (1,3,6,9)	96
Degarelix 240@40/240@60 (1,3,6,9)	101
Degarelix 240@40/240@60 (1,4,7,10)	111

Secondary outcomeNumber· 28 Days

Number of Participants With Testosterone <=0.5 ng/mL at Day 28

Group	Value (participants)
Degarelix 240@40/240@40 (1,3,6,9)	142
Degarelix 240@40/240@60 (1,3,6,9)	143
Degarelix 240@40/240@60 (1,4,7,10)	142

Secondary outcomeNumber· 12 or 13 months

Liver Function Tests

Group	Value (participants)
Degarelix 240@40/240@40 (1,3,6,9)	60
Degarelix 240@40/240@60 (1,3,6,9)	56
Degarelix 240@40/240@60 (1,4,7,10)	57

Secondary outcomeNumber· 12 or 13 months

Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline

Group	Value (participants)
Degarelix 240@40/240@40 (1,3,6,9)	4
Degarelix 240@40/240@60 (1,3,6,9)	6
Degarelix 240@40/240@60 (1,4,7,10)	2

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@40/240@40 (1,3,6,9)240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	–	28 / 150	117 / 150
Degarelix 240@40/240@60 (1,3,6,9)240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	–	25 / 150	110 / 150
Degarelix 240@40/240@60 (1,4,7,10)240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.	–	19 / 147	107 / 147

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

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

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Has given written consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention. * Is a male patient aged 18 years or over. * Has a baseline serum testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL. * Has an ECOG (Eastern Cooperative Oncology Group) score of 2. * Has a PSA value of 2 ng/mL. * Has a life expectancy of at least 13 months. Exclusion Criteria: * Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit. * Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit. * Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema. * Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. * Has a known or suspected hepatic or symptomatic biliary disease. * Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit. * Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation in this study or evaluation of study results. * Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator. * Has a mental incapacity or language barriers precluding adequate understanding or cooperation. * Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study. * Has previously participated in any degarelix study.

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