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NCT02685267 · ClinicalTrials.gov registry record · Phase 2

Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer

A Phase 2 study, sponsored by Prostate Cancer Clinical Trials Consortium.

Terminated
Registry status
Phase 2
Development phase
9
Enrollment target

NCT02685267: Clinical Trial Phase 2 study, sponsored by Prostate Cancer Clinical Trials Consortium.

NCT02685267 is a Phase 2 study that was terminated before completion, run by Prostate Cancer Clinical Trials Consortium. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02685267, a Phase 2 study, was terminated before completion, sponsored by Prostate Cancer Clinical Trials Consortium.

TERMINATED
Registry status
Phase 2
Development phase
9 participants
Enrollment target

Study Summary

This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide. The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.

Primary Outcome

The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines.

Interventions

  • DRUG Docetaxel
  • DRUG Prednisone
  • DRUG Enzalutamide

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2016-02
Est. Completion 2017-08
Phase Phase 2

Why NCT02685267 stopped before completion

NCT02685267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.

NCT02685267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02685267 about?

NCT02685267 is a clinical study titled "Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer". This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide. T...

What is the current status of trial NCT02685267?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2016-02. Estimated completion is 2017-08.

What interventions are being tested in trial NCT02685267?

The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), Enzalutamide (DRUG).

Who is sponsoring clinical trial NCT02685267?

This trial is sponsored by Prostate Cancer Clinical Trials Consortium, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02685267's enrollment target sits among peer trials

9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02685267, the US trial registry maintained by the National Library of Medicine. NCT02685267 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.