A Study of Degarelix in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00928434
First received: June 25, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose is to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) will show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Drug: Lupron (Leuprolide)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • PSA [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Reported Outcome Quality of Life intermittent treatment & continuous treatment [ Time Frame: Phase A Visit 1-7. Phase B Visit 8-15. ] [ Designated as safety issue: No ]
  • 2. PSA [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Enrollment: 405
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A. DI (Degarelix Intermittent) Drug: Degarelix
Experimental: B. DC (Degarelix Continuous) Drug: Degarelix
Active Comparator: C. LC (Leuprolide Continuous) Drug: Lupron (Leuprolide)

  Eligibility

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

Inclusion Criteria:

  • 18 years or older.
  • Raising PSA after prior treatment failure of localized prostate cancer.
  • Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
  • Has a screening testosterone with-in normal range ≥1.5 ng/mL.
  • Has ECOG score of ≤2.
  • CT scan, MRI or bone scan report documenting no evidence of metastasis to the bone or internal organs.
  • Life expectancy of at least 15 months.

Exclusion Criteria:

  • Taken hormone therapy in the last 6 months prior to entering this study.
  • Has a history of sever uncontrolled asthma, anaphylactic reactions, or sever urticaria and/or angioedema.
  • Has hypersensitivity towards any component of the study drug.
  • Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basel cell carcinoma of the skin within the last five years.
  • Abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
  • Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, 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.
  • Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
  • Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
  • Has previously participated in any Degarelix trial.
  • Is part of an ongoing trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928434

  Show 59 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00928434     History of Changes
Other Study ID Numbers: FE200486 CS37, RISPSA
Study First Received: June 25, 2009
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 01, 2014