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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00819247
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2002-05
• Study Completion: 2002-08
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Results First Submitted: 2009-01-22
• Results First Submitted QC: 2009-03-30
• Results First Posted: 2009-03-31
• Status Verified: 2011-05
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 80/80 + 40	Degarelix	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.
Degarelix 40/40 + 40	Degarelix	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.
Degarelix 80 + 20	Degarelix	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 Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24	Weeks 4-24	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	Six months	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	Weeks 12, 24	The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were \<= 4 nanogram/millliliter (normal level).
Percentage Change in Vital Signs and Body Weight	Baseline and Six months	Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24	Weeks 4-24
The Number of Participants With Abnormal Liver Function Tests	Six months	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.

Trial Locations

Locations (16)

Kings College Hospital; 🇬🇧 London, United Kingdom

Stirling Royal Infirmary; 🇬🇧 Stirling, United Kingdom

Bristol Royal Infirmary; 🇬🇧 Bristol, United Kingdom

Ayr Hospital; 🇬🇧 Ayr, United Kingdom

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Glan Clwyd Hospital; 🇬🇧 Denbighshire, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

St. Richards Hospital; 🇬🇧 Chichester, United Kingdom

Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom

Southern General Hospital; 🇬🇧 Glasgow, United Kingdom

St. Bartholemews Hospital; 🇬🇧 London, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Lister Hospital; 🇬🇧 Stevenage, United Kingdom

Morriston Hospital; 🇬🇧 Swansea, United Kingdom

Pindersfields General Hospital; 🇬🇧 Wakefield, United Kingdom