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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819156
• Other study ID #: FE200486 CS12
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: December 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: September 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• degarelix
Degarelix was given as subcutaneous injections.

Locations

Country	Name	City	State
Belgium	UCL Saint Luc	Brussels
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg	Leuven
Germany	Vivantes Klinikum am Urban	Berlin
Germany	Loretto Krankenhaus	Freiburg
Germany	Euromed AG Klinik	Fürth
Germany	Urologische Universitätsklinikum	Mannheim
Hungary	Bajcsy-Zsilinszky Hospital, Urology	Budapest
Hungary	Jahn Ferenc Dél Pesti Hospital, Urology	Budapest
Hungary	Pez Aladar County Hospital	Györ
Hungary	BAZ County Hospital	Miskolc
Hungary	Hospital of Local Gov. Szeged, Urology	Szeged
Hungary	MÁV Hospital, Urology	Szolnok
Netherlands	AMC	Amsterdam
Netherlands	Atrium MC	Heerlen
Poland	Wojewódzki Szpital Specjalisttyczny	Siedlce
Poland	Wojewódzki Szpital Specjalisttyczny	Slupsk
Romania	CF2 Hospital	Bucharest
Romania	Dr. Th Burghele Hospital	Bucharest
Romania	Fundeni Hospital	Bucharest
Romania	Sf. Ioan Hospital	Bucharest
Russian Federation	Botkin Clinical Hospital	Moscow
Russian Federation	City Hospital #1	Moscow
Russian Federation	City Hospital #29	Moscow
Russian Federation	City Hospital #50	Moscow
Russian Federation	City Hospital #60	Moscow
Russian Federation	Institute of Urology of MoH	Moscow
Russian Federation	"Andros" Urology Clinic	St Petersburg
Russian Federation	City Hospital #15	St Petersburg
Russian Federation	City Hospital #26	St Petersburg
Russian Federation	Military Medical Academy, Urology	St Petersburg
Russian Federation	Pavlov Medical School Outpatient	St Petersburg
Russian Federation	Pavlov medical School, Urology	St Petersburg
Russian Federation	Sct Petersburg State Medical Academy	St Petersburg
South Africa	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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  Netherlands,  Poland,  Romania,  Russian Federation,  South Africa, 

References & 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 prost — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	Day 28 - 364
Secondary	Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.	The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.	Day 28
Secondary	Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.	The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.	Day 3
Secondary	Days to 50 Percent Reduction in Prostate-Specific Antigen	Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.	Day 0 (post dose) to Day 364
Secondary	Days to 90 Percent Reduction in Prostate-Specific Antigen	Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.	Day 0 (post dose) to Day 364
Secondary	Days to Prostate-Specific Antigen Progression	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.	Day 0 (post dose) to Day 364
Secondary	Median Serum Testosterone Levels		Day 0 (Baseline), Days 1,3,7,14, and 364
Secondary	Median Prostate-specific Antigen Levels		Day 0 (Baseline), Days 3, 7, 14, and 364
Secondary	Median Values of Di-Hydrotestosterone		Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Secondary	Median Values for Serum Luteinizing Hormone		Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Secondary	Median Values for Follicle Stimulation Hormone		Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Secondary	The Number of Patients With Abnormal Liver Function Tests	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.	364 days
Secondary	The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight	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.	Day 364