Prostate Cancer
Conditions
Keywords
stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Brief summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.
Interventions
DRUGbicalutamide
DRUGGoserelin Acetate
DRUGdocetaxel
DRUGEstramustine phosphate sodium
DRUGacetylsalicylic acid
PROCEDUREconventional surgery
RADIATIONradiation therapy
Sponsors
Sanofi
AstraZeneca
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
0 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Locally advanced disease or at high risk for relapse * No clinically or radiologically suspected metastases * Prior lymphadenectomy required * Meets at least 1 of the following criteria for poor prognosis: * Gleason score greater than 7 * T3 or T4 disease * Prostate-specific antigen greater than 20 ng/mL * N1 disease PATIENT CHARACTERISTICS: Age * Under 80 Performance status * ECOG 0-2 Life expectancy * More than 10 years Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * AST and ALT no greater than 1.5 times upper limit of normal (ULN) * Bilirubin no greater than ULN Renal * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular * No uncontrolled or severe cardiovascular disease * No prior thrombosis Pulmonary * No prior pulmonary embolus Other * No active infection * No intolerance to aspirin * No other prior malignancy except basal cell skin cancer * No physical or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No prior hormonal therapy * No other concurrent hormonal therapy Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No other concurrent anticancer therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From randomization to disease progression or death, up to 15 years. | The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. |
| Biological response: Prostate-specific antigen (PSA) level | 3 months | The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml) |
| Cancer progression as measured by ultrasound | From randomization to disease progression, up to 15 years. | Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment |
| Clinical progression-free survival | From randomization to disease progression or death, up to 15 years. | The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation). |
| Overall survival | From randomization to death from any cause, up to 15 years. | The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care. |
| Acute and late toxicity during the study | Throughout study completion, up to 15 years. | The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death) determined by the investigator, will make it possible to assess the severity of the disorders. |
| Quality of life questionnaire - Core 30 (QLQ-C30) | At baseline, 3 months, and 1 year | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Countries
France
Outcome results
None listed