RBR-9ns5dbActive, not recruitingPhase 2
Abiraterone acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-naive, Who Received a Prior Diethylstiboestrol Therapy- 212082PCR2036
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Faculdade de Medicina do ABC
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Intervention
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •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); Eligible participants must maintain ADT
Exclusion Criteria
- •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)
Investigators
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