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A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Unique Dataset IDNCT00638690
SponsorCougar Biotechnology, IncData ProviderJanssenTotal Study Enrolled Patients1195Comparator (Control) Arm Enrolled Patients398RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeHormonesDataset TypeSDTM

Clinical Trial Title

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Trial Summary and Conditions

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit:

This was a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled study conducted at 147 sites in the U.S., Europe, Australia, and Canada comparing the efficacy and safety of abiraterone acetate and prednisone with placebo and prednisone in men with mCRPC whose disease had progressed on or after 1 or 2 chemotherapy regimens (at least one of which contained the taxane docetaxel). Planned enrollment was approximately 1,158 subjects. Subjects were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status score (0-1 versus 2), worst pain over the past 24 hours on the Brief Pain Inventory - Short Form (BPI-SF) (0-3 [absent] versus 4-10 [present]), 1 versus 2 prior chemotherapy regimens, and type of progression (PSA progression only versus radiographic progression with or without PSA progression) and were then randomly assigned in a 2:1 ratio to receive abiraterone acetate and prednisone or placebo and prednisone, respectively. Eligible subjects received abiraterone acetate 1 g (administered as 4 x 250-mg tablets) or 4 matching placebo tablets orally once daily continuously at least 1 hour before or 2 hours after a meal, and prednisone 5 mg orally twice daily. In regions where prednisone was not marketed, prednisolone was provided. The study consisted of a screening period (within 14 days prior to Cycle 1 Day 1), treatment period (until documented disease progression or unacceptable toxicity), and a follow-up period (follow-up for survival every 3 months up to 60 months [5 years]). While treatment was administered on a continuous schedule, each cycle of treatment was 28 days. Safety and dosing compliance were evaluated during the Cycle 1 Day 15 visit, on Day 1 of each subsequent cycle, at treatment discontinuation if applicable, and at the end-of-study visit.

Data Summary

Control arm data files include raw and SDTM data on safety, efficacy, demographic, and baseline disease characteristics.

Study Objectives

The primary objective of the study was to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains docetaxel. The secondary objectives were to further evaluate the safety profile of abiraterone acetate plus prednisone, further characterize the PK of abiraterone acetate when administered concurrently with prednisone, further explore the potential utility of CTCs as a surrogate for clinical benefit, and evaluate the impact of abiraterone acetate plus prednisone on health related quality of life (QOL).

Outcome Measures

The primary efficacy endpoint was overall survival (OS) as measured from the date of randomization to the date of death regardless of the cause. Key secondary efficacy endpoints included radiographic progression-free survival (PFS), prostate-specific antigen (PSA) response rate, time to PSA progression, objective response rate, and time to first skeletal-related events. Modified RECIST criteria were used to assess tumor response and radiographic PFS. Radiographic PFS was defined as the time from randomization to the first occurrence of radiographic progression or death. Objective response rate was defined as the proportion of subjects with a complete or partial response. Post-baseline PSA level was used to measure PSA response rate and time to PSA progression. Time to first skeletal-related events was measured as the time to a pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: COU-AA-301 Protocol_Redacted.pdf


DATA DICTIONARY: 301_Data_Dictionary.xls