Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Summary

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Conditions

• Castration Levels of Testosterone
• Metastatic Prostatic Adenocarcinoma
• Stage IV Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

DRUG

Abiraterone

Given PO

DRUG

Bicalutamide

Given PO

DRUG

Degarelix

Given via injection

DRUG

Docetaxel

intravenous

DRUG

Flutamide

Given PO

DRUG

Goserelin Acetate

Given SC

DRUG

Histrelin Acetate

Receive SC

DRUG

Leuprolide Acetate

Receive SC or IM

DRUG

Nilutamide

Given PO

PROCEDURE

Orchiectomy

Undergo bilateral orchiectomy

DRUG

Prednisone

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Standard radiation

PROCEDURE

Radical Prostatectomy

Standard surgery

DRUG

Triptorelin

injection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Brian Chapin · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-24

Primary Completion

2028-04-01

Completion

2031-10-01

FDA Device

Yes

Countries

• United States
• Chile
• Colombia
• Mexico
• Switzerland

Study Locations