Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

NCT ID: NCT00819156

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2005-09-30

Brief Summary

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 200/80

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Degarelix was given as subcutaneous injections.

Degarelix 200/120

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Degarelix was given as subcutaneous injections.

Degarelix 200/160

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Degarelix was given as subcutaneous injections.

Degarelix 240/80

Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Degarelix was given as subcutaneous injections.

Degarelix 240/120

Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Degarelix was given as subcutaneous injections.

Degarelix 240/160

Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Degarelix was given as subcutaneous injections.

Interventions

degarelix

Degarelix was given as subcutaneous injections.

Intervention Type: DRUG

Other Intervention Names

FE200486

Eligibility Criteria

Inclusion Criteria

• Written informed consent prior to any study related procedures
• Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
• ECOG score to be equal to or above 2
• Testosterone level within age-specific normal range
• PSA value equal to or above 2 ng/ml
• Life expectancy of at least 6 months

Exclusion Criteria

• Previous or current hormonal treatment of prostate cancer
• Recent or current treatment with any drugs modifying the testosterone level
• Candidate for curative treatment such as prostatectomy or radiotherapy
• History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
• Hypersensitivity towards any component of degarelix or mannitol
• Cancer disease within the last 5 years except for prostate cancer and some skin cancers
• Signs of liver impairment shown as elevated serum ALT or serum bilirubin
• Known hepatic disease
• Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
• Clinically significant disorder including 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 precluding adequate understanding or cooperation
• Having received an investigational product within the last 12 weeks preceding the trial
• Previous participation in this trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

UCL Saint Luc

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

UZ Gasthuisberg

Leuven, , Belgium

Vivantes Klinikum am Urban

Berlin, , Germany

Loretto Krankenhaus

Freiburg im Breisgau, , Germany

Euromed AG Klinik

Fürth, , Germany

Urologische Universitätsklinikum

Mannheim, , Germany

Bajcsy-Zsilinszky Hospital, Urology

Budapest, , Hungary

Jahn Ferenc Dél Pesti Hospital, Urology

Budapest, , Hungary

Pez Aladar County Hospital

Győr, , Hungary

BAZ County Hospital

Miskolc, , Hungary

Hospital of Local Gov. Szeged, Urology

Szeged, , Hungary

MÁV Hospital, Urology

Szolnok, , Hungary

AMC

Amsterdam, , Netherlands

Atrium MC

Heerlen, , Netherlands

Wojewódzki Szpital Specjalisttyczny

Siedlce, , Poland

Wojewódzki Szpital Specjalisttyczny

Słupsk, , Poland

CF2 Hospital

Bucharest, , Romania

Dr. Th Burghele Hospital

Bucharest, , Romania

Fundeni Hospital

Bucharest, , Romania

Sf. Ioan Hospital

Bucharest, , Romania

Botkin Clinical Hospital

Moscow, , Russia

City Hospital #1

Moscow, , Russia

City Hospital #29

Moscow, , Russia

City Hospital #50

Moscow, , Russia

City Hospital #60

Moscow, , Russia

Institute of Urology of MoH

Moscow, , Russia

"Andros" Urology Clinic

Saint Petersburg, , Russia

City Hospital #15

Saint Petersburg, , Russia

City Hospital #26

Saint Petersburg, , Russia

Military Medical Academy, Urology

Saint Petersburg, , Russia

Pavlov Medical School Outpatient

Saint Petersburg, , Russia

Pavlov medical School, Urology

Saint Petersburg, , Russia

Sct Petersburg State Medical Academy

Saint Petersburg, , Russia

370 Clarke Road

Glenwood, Durban, , South Africa

Pretoria Urology Hospital

Hatfield, Pretoria, , South Africa

WITS Medical School

Parktown, , South Africa

401B Medical Centre

Pietermaritzburg, , South Africa

Sunninghill Clinic

Sunninghill, , South Africa

Countries

Belgium; Germany; Hungary; Netherlands; Poland; Romania; Russia; South Africa

References

Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.

Reference Type: RESULT

PMID: 18538469 (View on PubMed)

Other Identifiers

FE200486 CS12

Identifier Type: -

Identifier Source: org_study_id