Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Summary

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, 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 antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Conditions

• Stage I Prostate Adenocarcinoma AJCC v7
• Stage II Prostate Adenocarcinoma AJCC v7
• Stage III Prostate Adenocarcinoma AJCC v7

Interventions

DRUG

Bicalutamide

Given orally (PO)

DRUG

Degarelix

Given IM

DRUG

Docetaxel

Given IV

RADIATION

External Beam Radiation Therapy

Undergo external beam radiation therapy

DRUG

Flutamide

Given PO

DRUG

Goserelin

Given IM

DRUG

Goserelin Acetate

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leuprolide

Given intramuscularly (IM)

DRUG

Leuprolide Acetate

Given IM

DRUG

Nilutamide

Drug

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Mark D Hurwitz · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-05

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• United States
• Canada
• Puerto Rico

Study Locations