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COMPLETED Phase 3

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

NCT00638690 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase 3 study 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. At least one of the previous chemotherapies must have contained docetaxel.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Abiraterone acetate
  • DRUG Prednisone/prednisolone

Study Locations (20)

California

  • — Beverly Hills
  • — Duarte
  • — Los Angeles
  • — Marina del Rey
  • — Sacramento
  • — San Diego
  • — San Francisco

Florida

  • — Boca Raton
  • — Fort Lauderdale
  • — Fort Myers
  • — West Palm Beach

Connecticut

  • — Bristol
  • — New Haven
  • — Stamford

Alabama

  • — Birmingham

Arizona

  • — Tucson

Colorado

  • — Aurora

Georgia

  • — Atlanta

Hawaii

  • — Honolulu

Trial Details

FieldValue
Enrollment Target 1,195 participants
Start Date 2008-05
Est. Completion 2012-10
Phase Phase 3

Sponsor

Cougar Biotechnology

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00638690

The ClinicalTrials.gov registry entry for NCT00638690 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cougar Biotechnology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00638690 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00638690 about?

NCT00638690 is a clinical study titled "Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy". This is a phase 3 study 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. At least one of the previous chemotherapies must have ...

What is the current status of trial NCT00638690?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,195 participants. The study started on 2008-05. Estimated completion is 2012-10.

What conditions does trial NCT00638690 study?

This clinical trial studies the following conditions: Prostatic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00638690?

The interventions under investigation include: Placebo (DRUG), Abiraterone acetate (DRUG), Prednisone/prednisolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00638690?

This trial is sponsored by Cougar Biotechnology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00638690 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial