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COMPLETED Phase 2

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

NCT00528866 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. 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. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.

Conditions Studied

Interventions

  • DRUG docetaxel
  • DRUG LHRH agonist
  • RADIATION 3-dimensional conformal radiation therapy
  • DRUG bicalutamide
  • DRUG flutamide

Study Locations (20)

California

  • Auburn Radiation Oncology — Auburn
  • Radiation Oncology Centers - Cameron Park — Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center — Carmichael
  • Radiation Oncology Center - Roseville — Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento
  • Mercy General Hospital — Sacramento
  • UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
  • Solano Radiation Oncology Center — Vacaville

Louisiana

  • Tulane Cancer Center Office of Clinical Research — Alexandria
  • Mary Bird Perkins Cancer Center - Baton Rouge — Baton Rouge
  • MBCCOP - LSU Health Sciences Center — New Orleans
  • CCOP - Ochsner — New Orleans

Colorado

  • Urology Center of Colorado — Denver
  • Poudre Valley Radiation Oncology — Fort Collins

Illinois

  • Cancer Institute at St. John's Hospital — Springfield
  • CCOP - Carle Cancer Center — Urbana

Arizona

  • Arizona Oncology Services Foundation — Phoenix

Delaware

  • CCOP - Christiana Care Health Services — Newark

Kentucky

  • Norton Suburban Hospital — Louisville

Maryland

  • Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2008-04
Est. Completion 2018-05-14
Phase Phase 2

Sponsor

Radiation Therapy Oncology Group

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00528866

The ClinicalTrials.gov registry entry for NCT00528866 describes a study currently listed as completed. It is categorized as Phase 2, 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 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 37 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 5 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: NCT00528866 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Louisiana, Colorado. 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 NCT00528866 about?

NCT00528866 is a clinical study titled "Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy". RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutam...

What is the current status of trial NCT00528866?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-04. Estimated completion is 2018-05-14.

What conditions does trial NCT00528866 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 NCT00528866?

The interventions under investigation include: docetaxel (DRUG), LHRH agonist (DRUG), 3-dimensional conformal radiation therapy (RADIATION), bicalutamide (DRUG), flutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00528866?

This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00528866 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Delaware, Illinois. 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