An Open Multi-Centre Trial, Investigating a hormonel drug (Degarelix)given once a month followed by a period without treatment (calledintermittent androgen deprivation) in Patients with Prostate CancerRequiring Androgen Deprivation Therapy
- Conditions
- Prostate CancerMedDRA version: 14.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-003931-19-BE
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Male
- Target Recruitment
- 220
1) Has given written informed consent before any trial-related activity is performed.
2) Has prostate cancer, and is in need of this type of 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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1) Has had previous or is currently under hormonal treatment of prostate cancer.
2) Is considered to be candidate for radical prostatectomy or radiotherapy.
3) Has a history of severe uncontrolled asthma and/or other severe allergic reactions.
4) Has hypersensitivity towards any component of degarelix.
5) Has had cancer within the last five years except prostate cancer and some types of skin cancer.
6) Has a severe disorder (other than prostate cancer) including but not limited to liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, as judged by the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ];Secondary Objective: Evaluate the time to PSA > 4 ng/mL in patient subgroups. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]<br><br>Evaluate the time to testosterone > 0,5 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]<br><br>Evaluate the degarelix plasma levels [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]<br><br>Evaluate safety and tolerability [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ];Primary end point(s): Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ];Timepoint(s) of evaluation of this end point: Time Frame: Up to 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Evaluate the time to PSA > 4 ng/mL in patient subgroups. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]<br><br>Evaluate the time to testosterone > 0,5 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]<br><br>Evaluate the degarelix plasma levels [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]<br><br>Evaluate safety and tolerability [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ];Timepoint(s) of evaluation of this end point: Time Frame: Up to 24 months