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

• bicalutamide (Drug), also known as CASODEX®
• Goserelin Acetate (Drug), also known as ZOLADEX®
• docetaxel (Drug)
• Estramustine phosphate sodium (Drug)
• acetylsalicylic acid (Drug), also known as Aspirin
• conventional surgery (Procedure)
• radiation therapy (Radiation)

Primary outcomes

• 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.

Sex: Male, ages: 0 Years to 79 Years

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

• Results publication: Fizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24. PMID 22119204
• Results publication: Fizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-7, 2010.
• Results publication: Fizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.
• Results publication: Fizazi K, Faivre L, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28. PMID 26028518

• Karim Fizazi, MD, PhD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris