Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: bicalutamide (Drug); buserelin (Drug); cyproterone acetate (Drug); docetaxel (Drug); estramustine phosphate sodium (Drug); flutamide (Drug); goserelin acetate (Drug); leuprolide acetate (Drug); nilutamide (Drug); triptorelin (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure); radiation therapy (Radiation)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: UNICANCER Official(s) and/or principal investigator(s): Karim Fizazi, MD, PhD, Study Chair, Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
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.
Clinical Details
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
Study design: Allocation: Randomized, Primary Purpose: Treatment
Primary outcome: Survival rate, in terms of clinical and biological remission at 8 yearsProstate-specific antigen level at 3 months Cancer progression as measured by ultrasound Survival without clinical remission Overall survival Toxicity Quality of life
Detailed description:
OBJECTIVES:
- Compare the 8-year survival rate, in terms of clinical and biological remission, of
patients with locally advanced prostate cancer or with a high risk of relapse treated
with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or
without docetaxel and estramustine given before local radiotherapy or prostatectomy.
- Compare the prostate-specific antigen level at 3 months in patients treated with these
regimens.
- Compare cancer progression by ultrasound in patients treated with these regimens.
- Compare survival without clinical remission of patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific
antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs
N1 or N2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or
bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily.
Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5.
Treatment repeats every 21 days for a total of 4 courses. Patients also receive
luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin
subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3
months.
- Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning
approximately 21 days after chemotherapy is completed, patients with N0 disease undergo
radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or
N2 disease undergo radiotherapy or no further local treatment.
Hormonal therapy continues in both arms for 3 years in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, at 3 months, and at 1 year.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this
study within 3 years.
Eligibility
Minimum age: N/A.
Maximum age: 79 Years.
Gender(s): Male.
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
Locations and Contacts
Centre Paul Papin, Angers 49100, France
Hopital Saint Andre, Bordeaux 33075, France
Institut Bergonie, Bordeaux 33076, France
Hopital Ambroise Pare, Boulogne-Billancourt F-92104, France
Centre Regional Francois Baclesse, Caen 14076, France
Polyclinique du Parc, Cholet 49300, France
Centre Hospitalier Universitaire Henri Mondor, Creteil 94000, France
Clinique Sainte-Marguerite, Hyeres 83400, France
Centre Hospitalier Departemental, La Roche Sur Yon 85025, France
Centre Hospital Universitaire Hop Huriez, Lille 59037, France
Centre Hospital Regional Universitaire de Limoges, Limoges 87042, France
Polyclinique des Quatre Pavillons, Lormont 33310, France
Centre Leon Berard, Lyon 69008, France
CHU de la Timone, Marseille 13385, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille 13273, France
Hopital Clinique Claude Bernard, Metz 57072, France
Hopital Notre-Dame de Bon Secours, Metz 57038, France
Centre Hospitalier General de Mont de Marsan, Mont-de-Marsan 40000, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier 34298, France
Hopital Lapeyronie-CHU Montpellier, Montpellier 34295, France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain 44805, France
Centre Catherine de Sienne, Nantes 02, France
Centre Antoine Lacassagne, Nice 06189, France
Hopital de la Croix St. Simon, Paris 75020, France
Hopital Europeen Georges Pompidou, Paris 75015, France
Hopital Saint Joseph, Paris 75674, France
Hopital Tenon, Paris 75970, France
Institut Curie Hopital, Paris 75248, France
Institut Jean Godinot, Reims 51056, France
Centre Eugene Marquis, Rennes 35042, France
Centre Hospitalier de Rodez, Rodez 12027, France
Centre Henri Becquerel, Rouen 76038, France
Centre Rene Huguenin, Saint Cloud 92211, France
Hopital Foch, Suresnes 92151, France
Institut Claudius Regaud, Toulouse 31052, France
Centre Hospitalier Universitaire Bretonneau de Tours, Tours 37044, France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy 54511, France
Institut Gustave Roussy, Villejuif F-94805, France
Additional Information
Starting date: November 2002
Last updated: February 23, 2012
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