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Antiandrogen

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-5 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Progression-free Survival
Secondary study objectives
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hormone therapy, estramustine, etoposide and paclitaxelExperimental Treatment8 Interventions
Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Bicalutamide
FDA approved
Flutamide
FDA approved
Estramustine
FDA approved
Goserelin
FDA approved
Leuprolide
FDA approved
Nilutamide
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,160 Total Patients Enrolled
26 Trials studying Prostate Cancer
53,509 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,129 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,919 Patients Enrolled for Prostate Cancer
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,575 Total Patients Enrolled
26 Trials studying Prostate Cancer
53,509 Patients Enrolled for Prostate Cancer
David C. Smith, MDStudy ChairUniversity of Michigan Rogel Cancer Center
7 Previous Clinical Trials
826 Total Patients Enrolled
3 Trials studying Prostate Cancer
80 Patients Enrolled for Prostate Cancer
~2 spots leftby Dec 2025
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