Metastatic Castration-Resistant Prostate Cancer MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
Male
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of abiraterone acetate with 4 alternative steroid treatment strategies related to symptoms associated with mineralocorticoid excess toxicities (ie, hypokalemia and/or hypertension) during the first 24 weeks of treatment in asymptomatic, chemotherapy-naïve, mCRPC subjects.;Secondary Objective: • To further characterize the global safety profile (including the incidence of mineralocorticoid excess toxicities [eg, hypokalemia and hypertension]). • To characterize mid-term and long-term exogenous glucocorticoid side effects. • To characterize the clinical benefit. To evaluate the impact on pain and quality of life (QoL) as measured by the EQ-5D-5L, Brief Pain Inventory - short form (BPI-SF) and Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) tools. • To collect medical resource utilization (MRU) data that may be used in future economic modeling (the construction and reporting of the economic model will be conducted separately from this study). • To evaluate overall survival. • To collect data on subsequent therapies for prostate cancer (time to next therapy for prostate cancer, time to initiation of chemotherapy, treatment duration, best response) following cessation of study treatment.;Primary end point(s): Number of participants experiencing neither hypokalemia nor hypertension treatment-emergent adverse events up to Week 24;Timepoint(s) of evaluation of this end point: Up to 24 Weeks after Day 1 of Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Up to 5 years after the start of study treatment of the first patient in the study.;Secondary end point(s): - Progression Free Survival - time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death; - Prostate specific antigen response rate - A PSA response is defined as a =50% decline from baseline according to the adapted PCWG2 criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show =50% decline from baseline; - Time to prostate specific antigen progression; - Objective response rate; - Time to opiate use for cancer pain; - Time to deterioration in Eastern Cooperative Oncology Group (ECOG) performance score by 1 point; - Number of participants with change in EQ-5D-5L score; - Number of participants with change in Brief Pain Inventory - short form (BPI-SF) score; - Number of participants with change in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) score; - Overall Survival; - Time to next therapy for prostate cancer; - Time to initiation of subsequent chemotherapy; - Treatment duration of subsequent chemotherapy. | — |
Countries
Belgium, Germany, Hungary, Italy, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed