Clinical trialNCT00030654CompletedPhase 3Interventional

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

SponsorRadiation Therapy Oncology GroupEnrollment21Prostate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Arif Hussain, MD
University of Maryland Greenebaum Cancer Center
Study Chair
clinicaltrials.gov ↗
Gregory P. Swanson, MD
Deaconess Medical Center, Spokane, Washington
Study Chair
clinicaltrials.gov ↗
Kenneth J. Pienta, MD, FACP
University of Michigan Rogel Cancer Center
Study ChairKOL profile →
clinicaltrials.gov ↗
Naomi S. Balzer-Haas, MD
Fox Chase Cancer Center
Study Chair
clinicaltrials.gov ↗
Primo N. Lara, MD
University of California, Davis
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

78 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Westmead Hospital
Westmead, New South Wales, Australia

Peru

Instituto de Enfermedades Neoplasicas
Lima, Peru

Puerto Rico

San Juan City Hospital
San Juan, Puerto Rico

United States

Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
Medical Center of Aurora - South Campus
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Ccop - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - St. Luke'S Medical Center
Denver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose
Denver, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Veterans Affairs Medical Center - Tampa (haley)
Tampa, Florida, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States

38 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bicalutamide →Docetaxel →Doxorubicin →Estramustine →Flutamide →Ketoconazole →Paclitaxel →Releasing hormone agonist therapyVinblastine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2002
Primary completion: 4 Feb 2005
Completion: 4 Feb 2005
Last update posted: 22 Oct 2020
Registered enrollment: 21
Registry id: NCT00030654

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.