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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00288080 |
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: bicalutamide Drug: buserelin Drug: docetaxel Drug: flutamide Drug: goserelin Drug: leuprolide acetate Drug: prednisone Drug: triptorelin Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: | Cancer Prostate Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer |
Estimated Enrollment: | 600 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Active Comparator
Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
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Drug: bicalutamide
Given orally
Drug: buserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: flutamide
Given orally
Drug: goserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: leuprolide acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: triptorelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Procedure: radiation therapy
Patients undergo radiotherapy 5 days a week for approximately 8 weeks.
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Arm II: Experimental
Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.
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Drug: bicalutamide
Given orally
Drug: buserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: docetaxel
Given IV
Drug: flutamide
Given orally
Drug: goserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: leuprolide acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: prednisone
Given orally
Drug: triptorelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Procedure: radiation therapy
Patients undergo radiotherapy 5 days a week for approximately 8 weeks.
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
PSA ≤ 150 ng/mL
Cannot have been obtained during any of the following time points:
No distant metastases by physical exam and bone scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for prostate cancer
Show 226 Study Locations |
Radiation Therapy Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Howard M. Sandler, MD | University of Michigan Cancer Center |
Investigator: | Seth Rosenthal, MD | Radiological Associates of Sacramento Medical Group at Sutter Cancer Center |
Investigator: | Kenneth J. Pienta, MD, FACP | University of Michigan Cancer Center |
Investigator: | Leonard G. Gomella, MD | Kimmel Cancer Center (KCC) |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Featured trial article 
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Study ID Numbers: | CDR0000462375, RTOG-0521 |
First Received: | February 6, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00288080 |
Health Authority: | Unspecified |
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