Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: degarelix	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of patients who achieved a testosterone level considered a castration level.

Secondary Outcome Measures:

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 [ Time Frame: Day 28 - 364 ] [ Designated as safety issue: No ]
Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Days to 50 Percent Reduction in Prostate-Specific Antigen [ Time Frame: Day 0 (post dose) to Day 364 ] [ Designated as safety issue: No ]
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
Days to 90 Percent Reduction in Prostate-Specific Antigen [ Time Frame: Day 0 (post dose) to Day 364 ] [ Designated as safety issue: No ]
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
Days to Prostate-Specific Antigen Progression [ Time Frame: Day 0 (post dose) to Day 364 ] [ Designated as safety issue: No ]
Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Median Serum Testosterone Levels [ Time Frame: Day 0 (Baseline), Days 1,3,7,14, and 364 ] [ Designated as safety issue: No ]
Median Prostate-specific Antigen Levels [ Time Frame: Day 0 (Baseline), Days 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
Median Values of Di-Hydrotestosterone [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
Median Values for Serum Luteinizing Hormone [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
Median Values for Follicle Stimulation Hormone [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
The Number of Patients With Abnormal Liver Function Tests [ Time Frame: 364 days ] [ Designated as safety issue: No ]
The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight [ Time Frame: Day 364 ] [ Designated as safety issue: No ]
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.

Enrollment:	189
Study Start Date:	February 2004
Study Completion Date:	September 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: degarelix Degarelix was given as subcutaneous injections. Other Name: FE200486
Experimental: 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.	Drug: degarelix Degarelix was given as subcutaneous injections. Other Name: FE200486
Experimental: 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.	Drug: degarelix Degarelix was given as subcutaneous injections. Other Name: FE200486
Experimental: 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.	Drug: degarelix Degarelix was given as subcutaneous injections. Other Name: FE200486
Experimental: 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.	Drug: degarelix Degarelix was given as subcutaneous injections. Other Name: FE200486
Experimental: 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.	Drug: degarelix Degarelix was given as subcutaneous injections. Other Name: FE200486

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819156

Show 39 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

Publications:

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. Epub 2008 May 8.

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00819156 History of Changes
Other Study ID Numbers:	FE200486 CS12
Study First Received:	January 7, 2009
Results First Received:	January 22, 2009
Last Updated:	December 20, 2011
Health Authority:	Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee Romania: Ministry of Public Health Romania: National Medicines Agency Hungary: National Institute of Pharmacy Netherlands: Ministry of Health, Welfare and Sport Netherlands: Independent Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: Ministry of Health South Africa: Department of Health South Africa: Human Research Ethics Committee

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013