Clinical trial NCT00738673: Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
Official title: An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Hormone refractory prostate cancer
Agonist treatment failure
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.


Eligibility criteria: Inclusion Criteria:

* Patient has given written informed consent before any trial-related activity is performed.
* Patient is 18 years or older.
* Histologically confirmed prostate cancer.
* Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
* Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of \>2.5 ng/mL within the last six months.
* Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Estimated life expectancy at least 12 months.

Exclusion Criteria:

* Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
* Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
* Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
* Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
* Known hypersensitivity towards any component of the investigational medical product.
* History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Known or suspected clinically significant liver and/or biliary disease.
* Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
* Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
* Previous participation in any degarelix trial.

Primary outcomes:
measure: Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
timeFrame: Day 0 (baseline), 3 months
Secondary outcomes:
measure: Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
timeFrame: Day 0 (baseline), 1 month
measure: Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
timeFrame: Day 0 (baseline), 2 months
measure: Participants at Testosterone Castrate Level Throughout the Study
timeFrame: up to month 12
measure: Change From Baseline in Serum Levels of Testosterone at the Last Visit
timeFrame: Day 0 (baseline), up to month 12 (last visit)
measure: Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
timeFrame: Day 0 (baseline), up to month 12 (last visit)
measure: Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
timeFrame: Day 0 (baseline), up to month 12 (last visit)
measure: Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
timeFrame: Day 0 (baseline), up to month 12 (last visit)
measure: Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
timeFrame: up to month 12
measure: Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
timeFrame: up to month 12
measure: Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
timeFrame: up to month 12
measure: Kaplan-Meier Estimate for Overall Survival
timeFrame: up to month 12
Other outcomes:
Locations:
city: Bautzen
country: Germany
facility: Urologische Praxis
city: Berlin
country: Germany
facility: Urologische Klinik
city: Berlin
country: Germany
facility: Urologische Praxis
city: Borken
country: Germany
facility: Urologische Praxis
city: Erkrath - Hochdal
country: Germany
facility: Urologische Praxis
city: Hagenow
country: Germany
facility: Urologische Praxis
city: Hamburg
country: Germany
facility: Martini Klinik
city: Husum
country: Germany
facility: Urologische Praxis
city: Kirchheim
country: Germany
facility: Urologische Praxis
city: Köln
country: Germany
facility: Urologische Praxis
city: Lauenburg/Elbe
country: Germany
facility: Urologische Praxis
city: Leipzig
country: Germany
facility: Urologische Praxis
city: Markkleeberg
country: Germany
facility: Urologische Praxis
city: Planegg
country: Germany
facility: Urologische Klinik
city: Rostock
country: Germany
facility: Wissenschaftskontor Nord
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: