Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse
Overview
- Phase
- Phase 3
- Intervention
- docetaxel
- Conditions
- Prostate Cancer
- Sponsor
- UNICANCER
- Enrollment
- 413
- Locations
- 38
- Primary Endpoint
- Clinical progression-free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Chemotherapy
Intervention: docetaxel
Chemotherapy
Intervention: bicalutamide
Chemotherapy
Intervention: Goserelin Acetate
Chemotherapy
Intervention: Estramustine phosphate sodium
Chemotherapy
Intervention: acetylsalicylic acid
Chemotherapy
Intervention: conventional surgery
Chemotherapy
Intervention: radiation therapy
Without Chemotherapy
Intervention: bicalutamide
Without Chemotherapy
Intervention: Goserelin Acetate
Without Chemotherapy
Intervention: conventional surgery
Without Chemotherapy
Intervention: radiation therapy
Outcomes
Primary Outcomes
Clinical progression-free survival
Time Frame: 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).
Cancer progression as measured by ultrasound
Time Frame: 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
Quality of life questionnaire - Core 30 (QLQ-C30)
Time Frame: 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.
Progression-free survival
Time Frame: 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
Time Frame: 3 months
The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)
Overall survival
Time Frame: 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
Time Frame: 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.