A randomised, parallel-arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of reduction in International Prostate Symptom Score (IPSS), in patients with lower urinary tract symptoms (LUTS) secondary to locally advanced prostate cancer - FE200486 CS28
- Conditions
- Prostate CancerMedDRA version: 9.1Level: PTClassification code 10060862Term: Prostate cancer
- Registration Number
- EUCTR2008-004338-26-GB
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 280
Patient has given written informed consent before any trial-related activity is performed.
Patients is 18 years or older.
Histologically confirmed prostate cancer (Gleason graded, all stages) in which endocrine treatment is indicated.
PSA level at screening >10 ng/mL.
TNM staging at baseline: any T, any N, any M.
IPSS =12.
Qmax =12 mL/sec (the voided volume must be =150 mL unless in acute retention or obstructed with a residual urine volulme>100 mL) at screening.
Eastern Co-operative Oncology Group (ECOG) score of ?2.
Estimated life expectancy at least 12 months.
The prostate size is >30 cubic centimetres measured by TRUS.
For patients who have received hormonal prostate cancer treatment: demonstrated response to the previous hormonal prostate cancer treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Any previous treatments for prostate cancer except for hormonal treatment that must have terminated at least 6 months prior to screening.
Previous transurethral resection of the prostate.
Use of urethral catheter at screening.
Is currently treated with a 5-alpha reductase inhibitors finasteride or dutasteride. If the patient has been treated with finasteride or dutasteride, the treatment must have been terminated at least 12 and 16 weeks, respectively, prior to screening.
Is currently treated with an a-adrenoceptor antagonist. If the patient has been treated with an a-adrenoceptor antagonist, the treatment must have been terminated at least 4 weeks prior to screening.
Patients who require external beam radiotherapy to be started at the same time as hormone therapy. N.B. Patients who are started on a 3-month course of neoadjuvant hormone therapy (trial investigational medicinal products) prior to radiotherapy can be included in this trial, as long as all trial procedures, including the 12 week TRUS to measure prostate volume, are completed before radiotherapy is started.
Has a corrected QT interval (using the Fridericia correction method) over 450 msec.
Has a history of or risk factors for Torsades de Pointes
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Hypersensitivity towards any component of the investigational products.
History or presence of another malignancy, other than prostate cancer or treated squamous or basal cell carcinoma of the skin, within the last five years.
Patient has a clinically significant disorder (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.
Mental incapacity or language barrier precluding adequate understanding or co-operation.
Receipt of an investigational drug within the last 28 days proceeding screening or longer if considered to possibly influence the outcome of the current trial.
Previous participation in any degarelix trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method