A Trial of Degarelix in Patients With Prostate Cancer - Full Text View

Purpose

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix Drug: Goserelin acetate	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Goserelin Goserelin acetate Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix [ Time Frame: From Day 28 to Day 364 ]
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin [ Time Frame: Day 3 to Day 364 ]
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.

Secondary Outcome Measures:

Serum Levels of Testosterone Over Time [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ]
Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ]
Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline [ Time Frame: At baseline, 10 months and 13 months ]
The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline [ Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months ]
IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.


Enrollment:	859
Study Start Date:	June 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Degarelix 240 mg/480 mg	Drug: Degarelix The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations). Other Names: Firmagon FE200486
Active Comparator: Goserelin acetate	Drug: Goserelin acetate The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants). Other Name: Zoladex

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older.
Has a histological confirmed prostate cancer Gleason graded).
Has a screening testosterone above 2.2 ng/mL.
Rising prostate-specific antigen (PSA).
Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
Has a life expectancy of at least one year.

Exclusion Criteria:

Current or previous hormone therapy.
Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Has a heart insufficiency.
Has a 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.
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 received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

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: NCT00946920

Show 126 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators


Study Director:	Clinical Development Support	Ferring Pharmaceuticals

More Information


Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00946920 History of Changes
Other Study ID Numbers:	FE200486 CS35 2008-005276-27 ( EudraCT Number )
Study First Received:	July 3, 2009
Results First Received:	February 14, 2014
Last Updated:	May 2, 2014

Additional relevant MeSH terms:


Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms	Genital Diseases, Male Prostatic Diseases Goserelin Antineoplastic Agents, Hormonal Antineoplastic Agents

ClinicalTrials.gov processed this record on July 07, 2017