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

Phase 1

• Conditions: Metastatic Castration-Resistant Prostate Cancer; MedDRA version: 16.0Level: 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-IT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-30
• Study Completion: 2018-06-05
• Last Update Posted: 21 December 2021

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 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

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;
- Has a pathological finding consistent with small cell carcinoma of the prostate;
- Has a liver or visceral organ metastasis.

Study & Design

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