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Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
NCT00430183 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
Conditions Studied
Interventions
- DRUG docetaxel
- DRUG LHRH agonist
- PROCEDURE surgery
Study Locations (20)
California
- Alta Bates Summit Comprehensive Cancer Center — Berkeley
- Peninsula Medical Center — Burlingame
- USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles
- Sutter Health - Western Division Cancer Research Group — Novato
- University of California Davis Cancer Center — Sacramento
- Naval Medical Center - San Diego — San Diego
- California Pacific Medical Center - Pacific Campus — San Francisco
- Sutter Pacific Medical Foundation — Santa Rosa
- Tahoe Forest Cancer Center — Truckee
- Sutter Solano Medical Center — Vallejo
Colorado
- University of Colorado Cancer Center at UC Health Sciences Center — Aurora
- Denver Health Medical Center — Denver
- Veterans Affairs Medical Center - Denver — Denver
- Shaw Regional Cancer Center — Edwards
- Valley View Hospital Cancer Center — Glenwood Springs
- Montrose Memorial Hospital Cancer Center — Montrose
Alaska
- Providence Cancer Center — Anchorage
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital — Fairbanks
Connecticut
- Helen and Harry Gray Cancer Center at Hartford Hospital — Hartford
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 788 participants |
| Start Date | 2007-05-08 |
| Est. Completion | 2030-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00430183
The ClinicalTrials.gov registry entry for NCT00430183 describes a study currently listed as active not recruiting. 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 788 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 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 3 interventions — of which docetaxel 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: NCT00430183 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Colorado, 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 NCT00430183 about?
NCT00430183 is a clinical study titled "Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer". RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop ...
What is the current status of trial NCT00430183?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 788 participants. The study started on 2007-05-08. Estimated completion is 2030-10.
What conditions does trial NCT00430183 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 NCT00430183?
The interventions under investigation include: docetaxel (DRUG), LHRH agonist (DRUG), surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00430183?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00430183 being conducted?
This trial has 20 study locations across Alaska, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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