Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

UNICANCER413 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

413

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 0 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (38)

Centre Paul Papin

Angers, France

Hopital Saint Andre

Bordeaux, France

Institut Bergonie

Bordeaux, France

Hopital Ambroise Pare

Boulogne-Billancourt, France

Centre Regional Francois Baclesse

Caen, France

Polyclinique du Parc

Cholet, France

Outcomes

Primary Outcomes

Progression-free survival

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.

Time frame: From randomization to disease progression or death, up to 15 years.

Biological response: Prostate-specific antigen (PSA) level

The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)

Time frame: 3 months

Cancer progression as measured by ultrasound

Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment

Time frame: From randomization to disease progression, up to 15 years.

Clinical progression-free survival

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).

Time frame: From randomization to disease progression or death, up to 15 years.

Overall survival

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.

Time frame: From randomization to death from any cause, up to 15 years.

Acute and late toxicity during the study

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.

Time frame: Throughout study completion, up to 15 years.

Quality of life questionnaire - Core 30 (QLQ-C30)

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.

Time frame: At baseline, 3 months, and 1 year