Prostate Cancer Clinical Trial

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

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.

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Full Description

OBJECTIVES:

Primary

To assess whether the addition of androgen suppression therapy and docetaxel to adjuvant radiotherapy improves freedom from progression.

Secondary

To assess freedom from local-regional progression, distant metastases, disease-free survival, prostate cancer specific survival, non-prostate cancer specific survival, overall survival, and time to biochemical (PSA) failure.
To evaluate treatment-related "acute" and "late" toxicity based on Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
To correlate genomic and proteomic biomarkers with the primary and secondary clinical endpoints utilizing archival prostatectomy tissue and pretreatment and prospectively collected serum/plasma.

OUTLINE: This is a multicenter study.

Androgen suppression therapy: Patients receive a luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin) as an injection AND an oral antiandrogen (flutamide 3 times daily or bicalutamide once daily) for up to 6 months.
Radiotherapy: Beginning 8 weeks after the initiation of androgen suppression therapy, patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once a day 5 days a week for up to approximately 8 weeks.
Chemotherapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses.

After the completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Pathologically proven adenocarcinoma of the prostate gland meeting one of the following criteria:

Gleason ≥ 7and post-operative PSA nadir > 0.2 ng/ml with any pathologic tumor (pT) classification
Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification
Must have undergone radical prostatectomy within the past year
PSA must be obtained within 6 weeks (42 days) prior to study registration

No lymph node or distant metastases (N0, M0), based upon the following minimum diagnostic workup:

History and physical examination within 8 weeks prior to study registration
Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on bone scan within 16 weeks prior to study registration
No pelvic lymph nodes > 1.5 cm in greatest dimension on CT scan or MRI of the pelvis within 16 weeks prior to study registration, unless the enlarged lymph node is biopsied and negative

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Absolute neutrophil count (ANC) ≥ 2,000/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Total bilirubin ≤ 1.2 times ULN
No other invasive malignancy within the past 3 years except non-melanomatous skin cancer

No active, severe co-morbidity, including any of the following:

Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
Transmural myocardial infarction within the past 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy

AIDS

HIV testing is not required for study entry
No prior allergic reaction to the study drug(s)

PRIOR CONCURRENT THERAPY:

No prior systemic chemotherapy for prostate cancer
More than 3 years since prior chemotherapy for a different cancer

No prior androgen deprivation for treatment of prostate cancer

Prior use of hormonal agents, such as finasteride or dutasteride, for treatment of benign prostatic hypertrophy is allowed
No prior radiotherapy to the region of the prostate that would result in overlap of radiotherapy fields

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT00528866

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 69 Locations for this study

See Locations Near You

Arizona Oncology Services Foundation
Phoenix Arizona, 85013, United States
Auburn Radiation Oncology
Auburn California, 95603, United States
Radiation Oncology Centers - Cameron Park
Cameron Park California, 95682, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael California, 95608, United States
Radiation Oncology Center - Roseville
Roseville California, 95661, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento California, 95815, United States
Mercy General Hospital
Sacramento California, 95819, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Solano Radiation Oncology Center
Vacaville California, 95687, United States
Urology Center of Colorado
Denver Colorado, 80211, United States
Poudre Valley Radiation Oncology
Fort Collins Colorado, 80528, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Cancer Institute at St. John's Hospital
Springfield Illinois, 62702, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Norton Suburban Hospital
Louisville Kentucky, 40207, United States
Tulane Cancer Center Office of Clinical Research
Alexandria Louisiana, 71315, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River Massachusetts, 02721, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
CentraCare Clinic - River Campus
Saint Cloud Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Regional Cancer Center at Singing River Hospital
Pascagoula Mississippi, 39581, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau Missouri, 63703, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
Nevada Cancer Institute
Las Vegas Nevada, 89135, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton New Jersey, 08053, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
University Medical Center at Princeton
Princeton New Jersey, 08540, United States
Mission Hospitals - Memorial Campus
Asheville North Carolina, 28801, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
Cancer Centers of North Carolina - Raleigh
Raleigh North Carolina, 27607, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Barberton Citizens Hospital
Barberton Ohio, 44203, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cancer Care Center, Incorporated
Salem Ohio, 44460, United States
Precision Radiotherapy at University Pointe
West Chester Ohio, 45069, United States
Cancer Treatment Center
Wooster Ohio, 44691, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Integris Oncology Services
Oklahoma City Oklahoma, 73112, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem Pennsylvania, 18015, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill Pennsylvania, 19026, United States
Fox Chase Cancer Center Buckingham
Furlong Pennsylvania, 18925, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia Pennsylvania, 19140, United States
Crozer-Chester Medical Center
Upland Pennsylvania, 19013, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray Utah, 84157, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls Wisconsin, 53051, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
McGill Cancer Centre at McGill University
Montreal Quebec, H2W 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT00528866

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

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