EUCTR2012-004331-23-BE
Active, not recruiting
Phase 1
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-Naïve and Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Sponsor
- Janssen-Cilag International NV
- Enrollment
- 144
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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