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Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)

NCT01751438 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-04-27

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if treatment with standard systemic therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery or radiation therapy is more effective at controlling prostate cancer than standard systemic therapy alone. The safety of this treatment combination will also be studied.

Conditions

Interventions

OTHER

Best Systemic Therapy (BST)

Group 1 will continue to receive best systemic therapy (BST).

OTHER

Best Systemic Therapy (BST) + Surgery or Radiation Therapy

Group 2 will receive best systemic therapy in addition to surgery to remove prostate or radiation therapy to the prostate. Treating physician will decide if surgery or radiation therapy is the best choice.

BEHAVIORAL

Questionnaires

Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete.

OTHER

Phone Call/Email

Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Brian F. Chapin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-18
Primary Completion
2023-04-19
Completion
2023-04-19

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01751438 on ClinicalTrials.gov