Status:
COMPLETED
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one par...
Detailed Description
This is a Phase 2, multinational (when medical research study takes place in more than one country), multicenter (when more than one hospital or medical school team work on a medical research study), ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer. Participants should demonstrate evidence of progression on DES or evidence of grades 3/4 toxicities on DES
- Metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)
- May have received prior androgen blockage (bicalutamide or flutamide) but must have been discontinued for least 28 days
- Ongoing androgen deprivation therapy (ADT) (luteinizing hormone-releasing hormone \[LHRH\] agonist or orchiectomy), with serum testosterone level of less than 50 nanogram per deciliter (1.7 nanomole per liter) and eligible participants must maintain ADT
Exclusion
- Active infection or other medical condition that would make prednisone use contraindicated
- Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 milligram (mg) prednisone per day
- Pathological finding consistent with small cell carcinoma of the prostate
- Known brain metastasis
- Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02217566
Start Date
September 23 2014
End Date
October 26 2018
Last Update
January 13 2020
Active Locations (4)
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1
Porto Alegre, Brazil
2
Rio de Janeiro, Brazil
3
Santo André, Brazil
4
São Paulo, Brazil