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NCT02057939 · ClinicalTrials.gov registry record · Phase 2

Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)

A Phase 2 study of Prostate Cancer, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
3
Study locations

NCT02057939 is a Phase 2 study of Prostate Cancer that has completed, run by Duke University. The registered enrollment target is 38 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT02057939, a Phase 2 study of Prostate Cancer, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in the absence of metastatic disease on CT and bone scans. In addition to standard ADT and radiation therapy, research participants will take enzalutamide once daily for six months. It is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy compared to the historical control data in a similar patients setting.

Conditions Studied

Interventions

  • RADIATION Radiation Therapy
  • DRUG enzalutamide
  • DRUG Androgen Deprivation

Study Locations (3)

North Carolina

  • Duke University Medical Center - Durham
  • Wake Forest Baptist Health - Winston-Salem

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2014-04
Est. Completion 2019-06-05
Phase Phase 2

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT02057939

The ClinicalTrials.gov registry entry for NCT02057939 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.

NCT02057939 reports 3 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, New Jersey.

Frequently Asked Questions

What is clinical trial NCT02057939 about?

NCT02057939 is a clinical study titled "Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)". The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have recurrent PSA-only prostate ...

What is the current status of trial NCT02057939?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2014-04. Estimated completion is 2019-06-05.

What conditions does trial NCT02057939 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT02057939?

The interventions under investigation include: Radiation Therapy (RADIATION), enzalutamide (DRUG), Androgen Deprivation (DRUG).

Who is sponsoring clinical trial NCT02057939?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02057939 being conducted?

This trial has 3 study locations across New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.