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.
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.
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
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There are 69 Locations for this study
Phoenix Arizona, 85013, United States
Auburn California, 95603, United States
Cameron Park California, 95682, United States
Carmichael California, 95608, United States
Roseville California, 95661, United States
Sacramento California, 95815, United States
Sacramento California, 95819, United States
San Francisco California, 94115, United States
Vacaville California, 95687, United States
Denver Colorado, 80211, United States
Fort Collins Colorado, 80528, United States
Newark Delaware, 19713, United States
Springfield Illinois, 62702, United States
Urbana Illinois, 61801, United States
Louisville Kentucky, 40207, United States
Alexandria Louisiana, 71315, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Fall River Massachusetts, 02721, United States
Detroit Michigan, 48202, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Pascagoula Mississippi, 39581, United States
Cape Girardeau Missouri, 63703, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89135, United States
Marlton New Jersey, 08053, United States
Newark New Jersey, 07112, United States
Princeton New Jersey, 08540, United States
Asheville North Carolina, 28801, United States
Charlotte North Carolina, 28233, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Cincinnati Ohio, 45267, United States
Salem Ohio, 44460, United States
West Chester Ohio, 45069, United States
Wooster Ohio, 44691, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73112, United States
Bethlehem Pennsylvania, 18015, United States
Drexel Hill Pennsylvania, 19026, United States
Furlong Pennsylvania, 18925, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19140, United States
Upland Pennsylvania, 19013, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57701, United States
Murray Utah, 84157, United States
Seattle Washington, 98101, United States
Menomonee Falls Wisconsin, 53051, United States
Milwaukee Wisconsin, 53226, United States
Montreal Quebec, H2W 1, Canada
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