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

NCT02057939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-06-26

Study results available
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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

Interventions

DRUG

enzalutamide

160 mg orally once daily for six months

DRUG

Androgen Deprivation

Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

RADIATION

Radiation Therapy

Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Andrew Armstrong, MD ScM FACP · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-03-02
Completion
2019-06-05

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057939 on ClinicalTrials.gov