NCT00819156

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
8 countries

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 31, 2009

Completed
Last Updated

November 30, 2023

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

January 7, 2009

Results QC Date

January 22, 2009

Last Update Submit

November 8, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364

    Number of patients who achieved a testosterone level considered a castration level.

    12 months

Secondary Outcomes (13)

  • Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28

    Day 28 - 364

  • Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.

    Day 28

  • Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.

    Day 3

  • Days to 50 Percent Reduction in Prostate-Specific Antigen

    Day 0 (post dose) to Day 364

  • Days to 90 Percent Reduction in Prostate-Specific Antigen

    Day 0 (post dose) to Day 364

  • +8 more secondary outcomes

Study Arms (6)

Degarelix 200/80

EXPERIMENTAL

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.

Drug: degarelix

Degarelix 200/120

EXPERIMENTAL

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.

Drug: degarelix

Degarelix 200/160

EXPERIMENTAL

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.

Drug: degarelix

Degarelix 240/80

EXPERIMENTAL

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.

Drug: degarelix

Degarelix 240/120

EXPERIMENTAL

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.

Drug: degarelix

Degarelix 240/160

EXPERIMENTAL

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.

Drug: degarelix

Interventions

degarelixDRUG

Degarelix was given as subcutaneous injections.

Also known as: FE200486
Degarelix 200/120Degarelix 200/160Degarelix 200/80Degarelix 240/120Degarelix 240/160Degarelix 240/80

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

UCL Saint Luc

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

UZ Gasthuisberg

Leuven, Belgium

Location

Vivantes Klinikum am Urban

Berlin, Germany

Location

Loretto Krankenhaus

Freiburg im Breisgau, Germany

Location

Euromed AG Klinik

Fürth, Germany

Location

Urologische Universitätsklinikum

Mannheim, Germany

Location

Bajcsy-Zsilinszky Hospital, Urology

Budapest, Hungary

Location

Jahn Ferenc Dél Pesti Hospital, Urology

Budapest, Hungary

Location

Pez Aladar County Hospital

Győr, Hungary

Location

BAZ County Hospital

Miskolc, Hungary

Location

Hospital of Local Gov. Szeged, Urology

Szeged, Hungary

Location

MÁV Hospital, Urology

Szolnok, Hungary

Location

AMC

Amsterdam, Netherlands

Location

Atrium MC

Heerlen, Netherlands

Location

Wojewódzki Szpital Specjalisttyczny

Siedlce, Poland

Location

Wojewódzki Szpital Specjalisttyczny

Słupsk, Poland

Location

CF2 Hospital

Bucharest, Romania

Location

Dr. Th Burghele Hospital

Bucharest, Romania

Location

Fundeni Hospital

Bucharest, Romania

Location

Sf. Ioan Hospital

Bucharest, Romania

Location

Botkin Clinical Hospital

Moscow, Russia

Location

City Hospital #1

Moscow, Russia

Location

City Hospital #29

Moscow, Russia

Location

City Hospital #50

Moscow, Russia

Location

City Hospital #60

Moscow, Russia

Location

Institute of Urology of MoH

Moscow, Russia

Location

"Andros" Urology Clinic

Saint Petersburg, Russia

Location

City Hospital #15

Saint Petersburg, Russia

Location

City Hospital #26

Saint Petersburg, Russia

Location

Military Medical Academy, Urology

Saint Petersburg, Russia

Location

Pavlov Medical School Outpatient

Saint Petersburg, Russia

Location

Pavlov medical School, Urology

Saint Petersburg, Russia

Location

Sct Petersburg State Medical Academy

Saint Petersburg, Russia

Location

370 Clarke Road

Glenwood, Durban, South Africa

Location

Pretoria Urology Hospital

Hatfield, Pretoria, South Africa

Location

WITS Medical School

Parktown, South Africa

Location

401B Medical Centre

Pietermaritzburg, South Africa

Location

Sunninghill Clinic

Sunninghill, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 18538469RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Clinical Development Support
Organization
Ferring Pharmaceuticals
DK0-Disclosure@ferring.com

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

February 1, 2004

Primary Completion

June 1, 2005

Study Completion

September 1, 2005

Last Updated

November 30, 2023

Results First Posted

March 31, 2009

Record last verified: 2011-12

Locations

PL(2)ZA(5)BE(3)RO(4)HU(6)RU(13)DE(4)NL(2)