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NCT00528866 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
A Phase 2 study of Prostate Cancer, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT00528866 is a Phase 2 study of Prostate Cancer that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 80 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00528866, a Phase 2 study of Prostate Cancer, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-04 |
| Est. Completion | 2018-05-14 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.
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.
NCT00528866 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Louisiana, Colorado.
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.
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).
Who is sponsoring clinical trial NCT00528866?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
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.
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