Clinical trial NCT00819156: Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Official title: An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 189
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: Day 28 - 364
measure: Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
timeFrame: Day 28
measure: Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
timeFrame: Day 3
measure: Days to 50 Percent Reduction in Prostate-Specific Antigen
timeFrame: Day 0 (post dose) to Day 364
measure: Days to 90 Percent Reduction in Prostate-Specific Antigen
timeFrame: Day 0 (post dose) to Day 364
measure: Days to Prostate-Specific Antigen Progression
timeFrame: Day 0 (post dose) to Day 364
measure: Median Serum Testosterone Levels
timeFrame: Day 0 (Baseline), Days 1,3,7,14, and 364
measure: Median Prostate-specific Antigen Levels
timeFrame: Day 0 (Baseline), Days 3, 7, 14, and 364
measure: Median Values of Di-Hydrotestosterone
timeFrame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
measure: Median Values for Serum Luteinizing Hormone
timeFrame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
measure: Median Values for Follicle Stimulation Hormone
timeFrame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
measure: The Number of Patients With Abnormal Liver Function Tests
timeFrame: 364 days
measure: The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
timeFrame: Day 364
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UCL Saint Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Freiburg
country: Germany
facility: Loretto Krankenhaus
city: Fürth
country: Germany
facility: Euromed AG Klinik
city: Mannheim
country: Germany
facility: Urologische Universitätsklinikum
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital, Urology
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél Pesti Hospital, Urology
city: Györ
country: Hungary
facility: Pez Aladar County Hospital
city: Miskolc
country: Hungary
facility: BAZ County Hospital
city: Szeged
country: Hungary
facility: Hospital of Local Gov. Szeged, Urology
city: Szolnok
country: Hungary
facility: MÁV Hospital, Urology
city: Amsterdam
country: Netherlands
facility: AMC
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Siedlce
country: Poland
facility: Wojewódzki Szpital Specjalisttyczny
city: Slupsk
country: Poland
facility: Wojewódzki Szpital Specjalisttyczny
city: Bucharest
country: Romania
facility: CF2 Hospital
city: Bucharest
country: Romania
facility: Dr. Th Burghele Hospital
city: Bucharest
country: Romania
facility: Fundeni Hospital
city: Bucharest
country: Romania
facility: Sf. Ioan Hospital
city: Moscow
country: Russian Federation
facility: Botkin Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Hospital #1
city: Moscow
country: Russian Federation
facility: City Hospital #29
city: Moscow
country: Russian Federation
facility: City Hospital #50
city: Moscow
country: Russian Federation
facility: City Hospital #60
city: Moscow
country: Russian Federation
facility: Institute of Urology of MoH
city: St Petersburg
country: Russian Federation
facility: "Andros" Urology Clinic
city: St Petersburg
country: Russian Federation
facility: City Hospital #15
city: St Petersburg
country: Russian Federation
facility: City Hospital #26
city: St Petersburg
country: Russian Federation
facility: Military Medical Academy, Urology
city: St Petersburg
country: Russian Federation
facility: Pavlov Medical School Outpatient
city: St Petersburg
country: Russian Federation
facility: Pavlov medical School, Urology
city: St Petersburg
country: Russian Federation
facility: Sct Petersburg State Medical Academy
city: Glenwood, Durban
country: South Africa
facility: 370 Clarke Road
city: Hatfield, Pretoria
country: South Africa
facility: Pretoria Urology Hospital
city: Parktown
country: South Africa
facility: WITS Medical School
city: Pietermaritzburg
country: South Africa
facility: 401B Medical Centre
city: Sunninghill
country: South Africa
facility: Sunninghill Clinic
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.