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Clinical Trials/RBR-9ns5db
RBR-9ns5db
Active, not recruiting
Phase 2

Abiraterone acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-naive, Who Received a Prior Diethylstiboestrol Therapy- 212082PCR2036

Faculdade de Medicina do ABC0 sitesApril 11, 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Malignant neoplasm of prostate. Prostatic Neoplasms Castration-Resistant
Sponsor
Faculdade de Medicina do ABC
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 11, 2016
End Date
TBD
Last Updated
2 years ago
Study Type
Intervention
Sex
Male

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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