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NCT03419234 · ClinicalTrials.gov registry record · Phase 2

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

A Phase 2 study of Castration-Resistant Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7, sponsored by ECOG-ACRIN Cancer Research Group.

Active
Registry status
Phase 2
Development phase
223
Enrollment target
20
Study locations

NCT03419234: Active Phase 2 study of Castration-Resistant Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7, sponsored by ECOG-ACRIN Cancer Research Group.

NCT03419234 is a Phase 2 study of Castration-Resistant Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 223 participants, above the 73-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (205% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03419234, a Phase 2 study of Castration-Resistant Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
223 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

Primary Outcome

PFS is defined as time from randomization to radiographic progression, symptomatic deterioration requiring discontinuation of treatment or death, whichever occurs first. Patients who died without documented radiographic progression or symptomatic deterioration and the death occurred more than 6.5 months after the date of last disease assessment were censored at the date of last disease assessment.

Conditions Studied

Castration-Resistant Prostate Carcinoma Stage IV Prostate Adenocarcinoma AJCC v7 Prostate Carcinoma Metastatic in the Bone Castration Levels of Testosterone Metastatic Prostate Carcinoma in the Soft Tissue

Interventions

  • DRUG Prednisone
  • DRUG Abiraterone Acetate
  • DRUG Cabazitaxel
  • DRUG Androgen deprivation therapy

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • PCR Oncology - Arroyo Grande
  • Sutter Auburn Faith Hospital - Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
  • Alta Bates Summit Medical Center-Herrick Campus - Berkeley
  • Mills-Peninsula Medical Center - Burlingame
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
  • Eden Hospital Medical Center - Castro Valley
  • Adventist Health Cancer Care Center Chico - Chico
  • Sutter Davis Hospital - Davis
  • Epic Care-Dublin - Dublin
  • Kaiser Permanente Dublin - Dublin
  • Bay Area Breast Surgeons Inc - Emeryville

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
  • John L McClellan Memorial Veterans Hospital - Little Rock

Arizona

  • CTCA at Western Regional Medical Center - Goodyear
  • Kingman Regional Medical Center - Kingman

Alaska

  • Fairbanks Memorial Hospital - Fairbanks

Trial Details

FieldValue
Enrollment Target 223 participants
Start Date 2018-04-26
Est. Completion 2026-04-01
Phase Phase 2
ECOG-ACRIN Cancer Research Group

75 total trials

What the registry record for NCT03419234 still lists

NCT03419234 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (205% higher).

The record links to 5 conditions, with Castration-Resistant Prostate Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Prednisone is the first listed.

NCT03419234 names 20 study sites across 4 states, led by California, Arkansas, Arizona.

Frequently Asked Questions

What is clinical trial NCT03419234 about?

NCT03419234 is a clinical study titled "Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel". This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can ca...

What is the current status of trial NCT03419234?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2018-04-26. Estimated completion is 2026-04-01.

What conditions does trial NCT03419234 study?

This clinical trial studies the following conditions: Castration-Resistant Prostate Carcinoma, Stage IV Prostate Adenocarcinoma AJCC v7, Prostate Carcinoma Metastatic in the Bone, Castration Levels of Testosterone, Metastatic Prostate Carcinoma in the Soft Tissue.

What interventions are being tested in trial NCT03419234?

The interventions under investigation include: Prednisone (DRUG), Abiraterone Acetate (DRUG), Cabazitaxel (DRUG), Androgen deprivation therapy (DRUG).

Who is sponsoring clinical trial NCT03419234?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03419234 being conducted?

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

Learn More About Clinical Trials

Similar trials for Castration-Resistant Prostate Carcinoma

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 NCT03419234's enrollment target sits among peer trials

223 4th of 43 higher than 40 of 43 other Castration-Resistant Prostate Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Castration-Resistant Prostate Carcinoma 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 NCT03419234, the US trial registry maintained by the National Library of Medicine. NCT03419234 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.