Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
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| ClinicalTrials.gov Identifier: NCT00055731 |
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Recruitment Status :
Completed
First Posted : March 7, 2003
Last Update Posted : January 18, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: bicalutamide Drug: Goserelin Acetate Drug: docetaxel Drug: Estramustine phosphate sodium Drug: acetylsalicylic acid Procedure: conventional surgery Radiation: radiation therapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 413 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | November 14, 2002 |
| Actual Primary Completion Date : | December 21, 2010 |
| Actual Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Chemotherapy |
Drug: bicalutamide
Other Name: CASODEX® Drug: Goserelin Acetate Other Name: ZOLADEX® Drug: docetaxel Drug: Estramustine phosphate sodium Drug: acetylsalicylic acid Other Name: Aspirin Procedure: conventional surgery Radiation: radiation therapy |
| Active Comparator: Without Chemotherapy |
Drug: bicalutamide
Other Name: CASODEX® Drug: Goserelin Acetate Other Name: ZOLADEX® Procedure: conventional surgery Radiation: radiation therapy |
- 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)
- 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
- 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).
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 0 Years to 79 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed adenocarcinoma of the prostate
- Locally advanced disease or at high risk for relapse
- No clinically or radiologically suspected metastases
- Prior lymphadenectomy required
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055731
Show 38 study locations
| Study Chair: | Karim Fizazi, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00055731 |
| Other Study ID Numbers: |
GETUG-12 - UC-0160/0203 CDR0000270970 EU-20238 |
| First Posted: | March 7, 2003 Key Record Dates |
| Last Update Posted: | January 18, 2023 |
| Last Verified: | January 2023 |
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stage III prostate cancer stage IIB prostate cancer stage IIA prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Aspirin Docetaxel Goserelin Bicalutamide Estramustine |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents |