Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

ClinicalTrials.gov ID: NCT00081159

Public ClinicalTrials.gov record NCT00081159. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Randomized Phase II Study Of Bone-Targeted Therapy In Advanced Androgen-Dependent Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.

Study identification

NCT ID: NCT00081159
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: M.D. Anderson Cancer Center; Other
Enrollment: 80 participants

Conditions and interventions

Conditions

Interventions

Drug · Procedure · Radiation

Eligibility (public fields only)

Age range: Not listed
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2004
Primary completion: Aug 31, 2014
Completion: Aug 31, 2014
Last update posted: Nov 9, 2016

2004 – 2014

United States locations

U.S. sites: 4
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
M.D. Anderson Cancer Center at Orlando	Orlando	Florida	32806-2134	—
CCOP - Wichita	Wichita	Kansas	67214-3882	—
M.D. Anderson Cancer Center at University of Texas	Houston	Texas	77030-4009	—
CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin	54449	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00081159, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 9, 2016 · Synced Sep 9, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00081159 live on ClinicalTrials.gov.

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