Skip to main content
OpenTrials
Completed

NCT Number: NCT00055731

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

0 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centre Paul Papin, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bicalutamide

Drug

Other names: CASODEX®

Goserelin acetate

Drug

Other names: ZOLADEX®

docetaxel

Drug

estramustine phosphate sodium

Drug

acetylsalicylic acid

Drug

Other names: Aspirin

conventional surgery

Procedure

radiation therapy

Radiation

Primary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • AstraZeneca
  • Sanofi

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2010
Study completion
2022
First posted
Mar 7, 2003
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.