Abiraterone with Different Steroid Medications Regimens for side effect prevention in [metastatic castrate-resistant] prostate cancer patients prior to chemotherapy treatment

Phase 1

• Conditions: Metastatic Castration-Resistant Prostate Cancer; MedDRA 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-DE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-08
• Study Completion: 2018-06-05
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 164

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
F.1.3.1 Number of subjects for this age range 105

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified