Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy
Source: ClinicalTrials.gov NCT01867710 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment |
70.6; 36.8; 60.0; 70.3 | — |
| SECONDARY Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 |
57.1; 70.6; 47.2; 79.5 | — |
| SECONDARY Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain |
1.6; 2.2; 2.5; 1.3 | — |
| SECONDARY Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale |
1.31; 1.37; 1.80; 0.97 | — |
| SECONDARY Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale |
0.89; 1.76; 1.52; 1.12 | — |
| SECONDARY Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score |
-0.0694; -0.0638; -0.0728; -0.0359 | — |
| SECONDARY Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS |
-4.5; -5.0; -6.6; -3.1 | — |
| SECONDARY Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score |
-0.98; -2.20; -2.46; -1.04; -0.01; 0.61 | — |
| SECONDARY Progression-Free Survival (PFS) |
16.16; 12.68; 8.51; 21.22 | — |
| SECONDARY Time to Prostate-Specific Antigen (PSA) Progression |
10.38; 10.22; 4.83; 18.56 | — |
| SECONDARY Objective Response Rate (ORR) |
42.1; 38.9; 60.0; 56.3 | — |
| SECONDARY Time to Opiate Use for Cancer-related Pain |
NA; NA; NA; NA | — |
| SECONDARY Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point |
NA; NA; NA; NA | — |
| SECONDARY Overall Survival |
34.07; 48.43; 27.96; 42.81 | — |
| SECONDARY Time to Next Prostate Cancer Therapy |
20.14; 19.48; 16.66; 28.29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01867710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.