West Cancer Center

PROSTATE: Metastatic; Before chemo; \"A031201\"

Phase III trial of enzalutamide versus enzalutamide, abiraterone, and prednisone for castration resistant metastatic prostate cancer

Title

Alliance A031201

Study Title

Phase III trial of enzalutamide versus enzalutamide, abiraterone, and prednisone for castration resistant metastatic prostate cancer

Site Link

NCT019449337

Malignancy

Prostate, castrate resistant prostate cancer, CRPC, hormone resistant prostate cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st line

Investigational Agent

Abiraterone and Enzalutamide

Drug Class

Antiandrogen (androgen activation and androgen synthesis)

Brad Somer, MD

Sponsor

Alliance for Clinical Trials in Oncology

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT01949337

Key Eligibility Criteria Details

Metastatic Prostate Cancer, asymptomatic or mildly symptomatic
Castrate resistance (testosterone Adenocarcinoma
Progressive disease on ADT defined as follows- either:
-2 rising PSA values at least 1 week apart
-Soft tissue disease progression by RECIST criteria (1.1)
-Bone disease progression (2 or more new lesions on bone scan)
ECOG PS 0-1
No prior taxane therapy
No prior abiraterone or enzalutamide
No prior ketoconazole for prostate CA
No prior metastatic XRT
No plan for palliative procedures for bone pain
No structurally unstable bone lesions
No brain mets_

Objective

Primary- OS; Secondary- Safety, PFS, ORR, biomarkers

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

AdenocarcinomaNo neuroendocrine differentiation or small-cell features

Dosing Frequency

Abiraterone 1000mg PO qday, Prednisone 5mg PO qday

Control Agents

Enzalutamide 160mg PO qday

Study Protocol

Randomized

Yes