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

Unicancer

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Goserelin Acetate; Drug: acetylsalicylic acid; Drug: Estramustine phosphate sodium; Radiation: radiation therapy; Drug: docetaxel; Drug: bicalutamide; Procedure: conventional surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00055731

EU-20238

GETUG-12 - UC-0160/0203

CDR0000270970

Details and patient eligibility

About

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.

Enrollment: 413 patients

Sex: Male

Ages: Under 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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413 participants in 2 patient groups

Chemotherapy

Experimental group

Treatment:

Drug: Estramustine phosphate sodium

Radiation: radiation therapy

Drug: docetaxel

Procedure: conventional surgery

Drug: bicalutamide

Drug: acetylsalicylic acid

Drug: Goserelin Acetate

Without Chemotherapy

Active Comparator group

Treatment:

Radiation: radiation therapy

Procedure: conventional surgery

Drug: bicalutamide

Drug: Goserelin Acetate