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COMPLETED Phase 3

S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

NCT00004124 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.

Conditions Studied

Interventions

  • DRUG prednisone
  • DRUG goserelin
  • DRUG bicalutamide
  • DRUG mitoxantrone hydrochloride

Study Locations (20)

California

  • Alta Bates Comprehensive Cancer Center — Berkeley
  • Peninsula Medical Center — Burlingame
  • California Cancer Care, Incorporated — Greenbrae
  • Marin Cancer Institute at Marin General Hospital — Greenbrae
  • Sutter Health - Western Division Cancer Research Group — Greenbrae
  • Naval Medical Center - San Diego — San Diego
  • San Francisco General Hospital Medical Center — San Francisco
  • UCSF Comprehensive Cancer Center — San Francisco
  • California Pacific Medical Center - California Campus — San Francisco
  • Veterans Affairs Medical Center - San Francisco — San Francisco
  • Cancer Center of Santa Barbara — Santa Barbara
  • Sansum Medical Clinic — Santa Barbara
  • Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara — Santa Barbara

Arizona

  • Banner Thunderbird Medical Center — Glendale
  • Banner Good Samaritan Medical Center — Phoenix
  • CCOP - Western Regional, Arizona — Phoenix

Alaska

  • Alaska Regional Hospital Cancer Center — Anchorage
  • Providence Cancer Center — Anchorage

Arkansas

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock
  • Highlands Oncology Group - Springdale — Springdale

Trial Details

FieldValue
Enrollment Target 983 participants
Start Date 1999-10-15
Est. Completion 2018-05-01
Phase Phase 3

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00004124

The ClinicalTrials.gov registry entry for NCT00004124 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 983 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions — of which prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00004124 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00004124 about?

NCT00004124 is a clinical study titled "S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer". RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormo...

What is the current status of trial NCT00004124?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 983 participants. The study started on 1999-10-15. Estimated completion is 2018-05-01.

What conditions does trial NCT00004124 study?

This clinical trial studies the following conditions: Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00004124?

The interventions under investigation include: prednisone (DRUG), goserelin (DRUG), bicalutamide (DRUG), mitoxantrone hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00004124?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00004124 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial