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COMPLETED Phase 3

S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00004001 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

Conditions Studied

Interventions

  • DRUG prednisone
  • DRUG docetaxel
  • DRUG mitoxantrone
  • DRUG estramustine

Study Locations (16)

Iowa

  • CCOP - Cedar Rapids Oncology Project — Cedar Rapids
  • CCOP - Iowa Oncology Research Association — Des Moines
  • Siouxland Hematology-Oncology — Sioux City

North Dakota

  • Medcenter One Health System — Bismarck
  • CCOP - Merit Care Hospital — Fargo
  • Altru Health System — Grand Forks

Illinois

  • CCOP - Illinois Oncology Research Association — Peoria
  • CCOP - Carle Cancer Center — Urbana

Minnesota

  • Mayo Clinic Cancer Center — Rochester
  • CentraCare Health Plaza — Saint Cloud

South Dakota

  • Rapid City Regional Hospital — Rapid City
  • CCOP - Sioux Community Cancer Consortium — Sioux Falls

Arizona

  • CCOP - Scottsdale Oncology Program — Scottsdale

Florida

  • Mayo Clinic — Jacksonville

Nebraska

  • CCOP - Missouri Valley Cancer Consortium — Omaha

Trial Details

FieldValue
Enrollment Target 770 participants
Start Date 1999-10
Est. Completion 2007-01
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 NCT00004001

The ClinicalTrials.gov registry entry for NCT00004001 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 770 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: NCT00004001 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Iowa, North Dakota, Illinois. 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 NCT00004001 about?

NCT00004001 is a clinical study titled "S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy". RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effec...

What is the current status of trial NCT00004001?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 1999-10. Estimated completion is 2007-01.

What conditions does trial NCT00004001 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 NCT00004001?

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

Who is sponsoring clinical trial NCT00004001?

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 NCT00004001 being conducted?

This trial has 16 study locations across Arizona, Florida, Illinois, Iowa, Minnesota. 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