Abiraterone with Different Steroid Medications Regimens for side effect prevention in [metastatic castrate-resistant] prostate cancer patients prior to chemotherapy treatment
- Conditions
- Metastatic Castration-Resistant Prostate CancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004331-23-BE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 144
-Have a histologically or cytologically confirmed adenocarcinoma of the prostate
- Have metastatic disease documented by positive bone scan or by computed tomography or magnetic resonance imaging
- Have prostate cancer progression documented by prostate specific antigen according to Prostate Cancer Working Group 2 or radiographic progression according to modified RECIST (response evaluation criteria in solid tumors, v1.1) criteria
-Be asymptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic
-Be surgically or medically castrated, with testosterone levels of <50 ng/dL (<2.0 nmol/L). If the subject is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (subjects who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Day 1, Cycle 1 and must be continued throughout the study
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 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
-Has a history of pituitary or adrenal dysfunction
-Has an active infection or other medical condition that would contraindicate corticosteroid use
-Has any chronic medical condition requiring corticosteroid treatment or has received prior corticosteroid treatment for prostate cancer
-Has a pathological finding consistent with small cell carcinoma of the prostate
-Has a known brain metastasis
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