Phase 2
Completed N=46
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
Source: ClinicalTrials.gov NCT02217566 ↗Enrolled (actual)
46
Serious AEs
23.9%
Results posted
Jan 2020
Primary outcomePrimary: Time to Prostate-specific Antigen (PSA) Progression — 7.3 Months
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 part of the body to another) castration (any action, surgical, chemical, or otherwise, by which a male loses the functions of the testes) resistant prostate cancer (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC), chemo-naive (treatment of cancer is not done using drugs), who received a prior diethylstilbestrol therapy (DES).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Prostate-specific Antigen (PSA) Progression |
7.3 | — |
| SECONDARY Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response |
57.50 | — |
| SECONDARY Overall Survival |
29.6 | — |
| SECONDARY Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score |
19.44 | — |
| SECONDARY Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score |
15.15 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
45; 11 | — |
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) and 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)
Data sourced from ClinicalTrials.gov (NCT02217566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.