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A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy

NCT02849990 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-01-13

Study results available
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Summary

This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.

Conditions

  • Stage III Prostate Adenocarcinoma AJCC v7
  • Stage III Prostate Cancer AJCC v7
  • Stage IV Prostate Adenocarcinoma AJCC v7
  • Stage IV Prostate Cancer AJCC v7

Interventions

DRUG

Abiraterone Acetate

Given PO

DRUG

Apalutamide

Given PO

DRUG

Degarelix

Given SC

DRUG

Indomethacin

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative study

DRUG

Prednisone

Given PO

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Michael Schweizer · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-12-10
Completion
2020-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT02849990 on ClinicalTrials.gov