Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

NCTNCT00819247Other idFE200486 CS02

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 129 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United Kingdom
Start: Mar 2001
Primary completion: May 2002
Completion: Aug 2002
First posted: 8 Jan 2009 (estimated)
Last update posted: 9 Nov 2023
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

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

200120022003

Ph 2
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
NCT00819247
Mar 2001 to Aug 2002

Registry summary

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

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

Interventions

DegarelixDrug

Arms3

Experimental
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
Experimental
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
Experimental
Degarelix 80 + 20
Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Time frame · Weeks 1,2,4,8,12,16,20,24

Secondary outcomes(6)

Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Time frame · Weeks 4-24
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
Time frame · Weeks 4-24
Registry description
Participants with one testoterone value \> 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
Time frame · Six months
Registry description
Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) \>=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of \<=50% compared to baseline at week 12 (3) increase of \>=10 nanogram/milliliter compared to nadir from week 4.
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Time frame · Weeks 12, 24
Registry description
The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were \<= 4 nanogram/millliliter (normal level).
The Number of Participants With Abnormal Liver Function Tests
Time frame · Six months
Registry description
The number of participants who had abnormal \[defined as above upper limit of normal range (ULN)\] alanine aminotransferase (ALT), participants with ALT increases \> 3x ULN, and participants with ALT increases \> 3x ULN with concurrent increases in bilirubin \> 1.5 ULN.
Percentage Change in Vital Signs and Body Weight
Time frame · Baseline and Six months
Registry description
Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.

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· Weeks 1,2,4,8,12,16,20,24

Number of Participants With Testosterone <0.5 Nanogram/Milliliter

Group	Value (participants)
Degarelix 80/80 + 40	38
Degarelix 40/40 + 40	32
Degarelix 80 + 20	27

Secondary and other outcome results(6)

Secondary outcomeNumber· Weeks 4-24

Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24

Group	Value (participants)
Degarelix 80/80 + 40	28
Degarelix 40/40 + 40	27
Degarelix 80 + 20	20

Secondary outcomeNumber· Weeks 4-24

Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24

Group	Value (participants)
Degarelix 80/80 + 40	29
Degarelix 40/40 + 40	29
Degarelix 80 + 20	25

Secondary outcomeNumber· Six months

Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen

Group	Value (participants)
Degarelix 80/80 + 40	0
Degarelix 40/40 + 40	0
Degarelix 80 + 20	0

Secondary outcomeNumber· Weeks 12, 24

Number of Participants With Normal Prostate-specific Antigen Levels During the Study

Group	Value (participants)
Degarelix 80/80 + 40	18
Degarelix 40/40 + 40	18
Degarelix 80 + 20	16

Secondary outcomeNumber· Six months

The Number of Participants With Abnormal Liver Function Tests

Group	Value (participants)
Degarelix 80/80 + 40	13
Degarelix 40/40 + 40	14
Degarelix 80 + 20	12

Secondary outcomeMedian· Baseline and Six months

Percentage Change in Vital Signs and Body Weight

Group	Value (percentage)
Degarelix 80/80 + 40	0.0
Degarelix 40/40 + 40	-0.6
Degarelix 80 + 20	0.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 80/80 + 40Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.	–	3 / ?	38 / ?
Degarelix 40/40 + 40Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.	–	8 / ?	38 / ?
Degarelix 80 + 20Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.	–	6 / ?	32 / ?

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: * Signed informed consent before any trial related activity * Proven prostate cancer with a need for endocrine treatment * Testosterone level within the normal range for the age Exclusion Criteria: * Previous or current hormonal treatment of prostate cancer * Candidate for prostatectomy or radiotherapy * History of severe asthma, anaphylactic reactions or Quincke's Oedema * Hypersensitivity towards any component of FE200486 * Cancer disease within the last ten years except for prostate cancer and some skin cancers * Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator * Mental incapacity or language barrier * Having received an investigational product within the last 12 weeks preceding the trial * Previous participation in this trial

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