Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Ferring

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Bicalutamide; Drug: Goserelin; Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00831233

FE200486 CS28

2008-004338-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Enrollment: 42 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has given written informed consent before any trial-related activity is performed
• Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion criteria

• Previous treatment for prostate cancer
• Previous trans-urethral resection of the prostate
• Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
• Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
• Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Hypersensitivity towards any component of the investigational product
• Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
• Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Degarelix 240 mg/80 mg

Experimental group

Description:

Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)

Treatment:

Drug: Degarelix

Goserelin (3.6 mg) + bicalutamide (50 mg)

Active Comparator group

Description:

Goserelin (3.6 mg) + bicalutamide (50 mg)

Treatment:

Drug: Goserelin

Drug: Bicalutamide