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

• ClinicalTrials.gov Identifier: NCT00055731
• Recruitment Status: Completed
• First Posted: March 7, 2003
• Last Update Posted: January 18, 2023
• Sponsor: UNICANCER
• Collaborators: Sanofi; AstraZeneca
• Information provided by (Responsible Party): UNICANCER

Tracking Information

• First Submitted Date: March 6, 2003
• First Posted Date: March 7, 2003
• Last Update Posted Date: January 18, 2023
• Actual Study Start Date: November 14, 2002
• Actual Primary Completion Date: December 21, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2021)

• 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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• 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

Study Arms

• Experimental: Chemotherapy
  Interventions:

  • Drug: bicalutamide
  • Drug: Goserelin Acetate
  • Drug: docetaxel
  • Drug: Estramustine phosphate sodium
  • Drug: acetylsalicylic acid
  • Procedure: conventional surgery
  • Radiation: radiation therapy
• Active Comparator: Without Chemotherapy
  Interventions:

  • Drug: bicalutamide
  • Drug: Goserelin Acetate
  • Procedure: conventional surgery
  • Radiation: radiation therapy

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 19, 2021): 413
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 31, 2022
• Actual Primary Completion Date: December 21, 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 0 Years to 79 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00055731
• Other Study ID Numbers: GETUG-12 - UC-0160/0203; CDR0000270970; EU-20238
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UNICANCER
• Original Responsible Party: Not Provided
• Current Study Sponsor: UNICANCER
• Original Study Sponsor: Same as current

Collaborators

• Sanofi
• AstraZeneca

Investigators

• Study Chair: Karim Fizazi, MD, PhD; Gustave Roussy, Cancer Campus, Grand Paris

• PRS Account: UNICANCER
• Verification Date: January 2023