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

Janssen-Cilag International NV0 个研究点目标入组 164 人开始时间: 2013年5月30日最近更新: 2021年12月21日

试验速览

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•- Have a histologically or cytologically confirmed adenocarcinoma of the prostate;
•- Have metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT or MRI;
•- Have prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST (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;
•- Has a pathological finding consistent with small cell carcinoma of the prostate;
•- Has a liver or visceral organ metastasis.

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