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NCT01605227 · ClinicalTrials.gov registry record · Phase 3

Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100

A Phase 3 study of Prostate Cancer and Pain, sponsored by Exelixis.

Completed
Registry status
Phase 3
Development phase
1,028
Enrollment target
20
Study locations

NCT01605227: Completed Phase 3 study of Prostate Cancer and Pain, sponsored by Exelixis.

NCT01605227 is a Phase 3 study of Prostate Cancer and Pain that has completed, run by Exelixis. The registered enrollment target is 1,028 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (69% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01605227, a Phase 3 study of Prostate Cancer and Pain, has completed, sponsored by Exelixis.

COMPLETED
Registry status
Phase 3
Development phase
1,028 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

Primary Outcome

The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.

Conditions Studied

Prostate Cancer Pain Prostatic Neoplasms Castration-resistant Prostate Cancer

Interventions

  • DRUG prednisone
  • DRUG cabozantinib

Study Locations (20)

California

  • - Duarte
  • - Highland
  • - La Jolla
  • - Los Angeles
  • - Montebello
  • - Orange
  • - Palo Alto
  • - Rancho Mirage
  • - San Marcos
  • - St. Helena
  • - Vallejo

Arizona

  • - Phoenix
  • - Scottsdale
  • - Tucson

Connecticut

  • - New Haven
  • - Southington

Alabama

  • - Birmingham

Alaska

  • - Anchorage

Arkansas

  • - Jonesboro

Colorado

  • - Aurora

Trial Details

FieldValue
Enrollment Target 1,028 participants
Start Date 2012-07
Est. Completion 2015-03
Phase Phase 3
Exelixis

48 total trials

What the finished NCT01605227 record still lists

NCT01605227 is an interventional study that assigns participants to a tested intervention. Its 1,028 participants enrollment target places it among the larger protocols in the corpus, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (69% higher).

The record links to 4 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which prednisone is the first listed.

NCT01605227 names 20 study sites across 7 states, led by California, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01605227 about?

NCT01605227 is a clinical study titled "Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100". This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MD...

What is the current status of trial NCT01605227?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,028 participants. The study started on 2012-07. Estimated completion is 2015-03.

What conditions does trial NCT01605227 study?

This clinical trial studies the following conditions: Prostate Cancer, Pain, Prostatic Neoplasms, Castration-resistant Prostate Cancer.

What interventions are being tested in trial NCT01605227?

The interventions under investigation include: prednisone (DRUG), cabozantinib (DRUG).

Who is sponsoring clinical trial NCT01605227?

This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01605227 being conducted?

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

Learn More About Clinical Trials

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01605227's enrollment target sits among peer trials

1,028 55th of 735 higher than 681 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01605227, the US trial registry maintained by the National Library of Medicine. NCT01605227 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.