NCT00738673

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

15 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

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

December 1, 2012

Enrollment Period

3.4 years

First QC Date

August 18, 2008

Results QC Date

December 12, 2012

Last Update Submit

December 12, 2012

Conditions

Prostate Cancer

Keywords

Hormone refractory prostate cancerAgonist treatment failure

Outcome Measures

Primary Outcomes (1)

  • Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline

    Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level

    Day 0 (baseline), 3 months

Secondary Outcomes (11)

  • Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline

    Day 0 (baseline), 1 month

  • Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline

    Day 0 (baseline), 2 months

  • Participants at Testosterone Castrate Level Throughout the Study

    up to month 12

  • Change From Baseline in Serum Levels of Testosterone at the Last Visit

    Day 0 (baseline), up to month 12 (last visit)

  • Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit

    Day 0 (baseline), up to month 12 (last visit)

  • +6 more secondary outcomes

Study Arms (1)

Degarelix

EXPERIMENTAL

Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Drug: degarelix

Interventions

degarelixDRUG

Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Also known as: FE200486
Degarelix

Eligibility Criteria

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

You may qualify if:

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Estimated life expectancy at least 12 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Urologische Praxis

Bautzen, Germany

Location

Urologische Klinik

Berlin, Germany

Location

Urologische Praxis

Berlin, Germany

Location

Urologische Praxis

Borken, Germany

Location

Urologische Praxis

Cologne, Germany

Location

Urologische Praxis

Erkrath - Hochdal, Germany

Location

Urologische Praxis

Hagenow, 19230, Germany

Location

Martini Klinik

Hamburg, Germany

Location

Urologische Praxis

Husum, Germany

Location

Urologische Praxis

Kirchheim, Germany

Location

Urologische Praxis

Lauenburg/Elbe, Germany

Location

Urologische Praxis

Leipzig, Germany

Location

Urologische Praxis

Markkleeberg, Germany

Location

Urologische Klinik

Planegg, Germany

Location

Wissenschaftskontor Nord

Rostock, Germany

Location

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 18, 2013

Results First Posted

January 18, 2013

Record last verified: 2012-12

Locations

DE(15)