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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000270970 | |||
| EU-20238 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental |
| |
| Without Chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicalutamide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 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. | From randomization to disease progression or death, up to 15 years. |
| Biological response: Prostate-specific antigen (PSA) level | The biological response is defined as a non-detectable serum PSA level (<0.1 ng/ml) | 3 months |
| Cancer progression as measured by ultrasound | Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment | From randomization to disease progression, up to 15 years. |
| Clinical progression-free survival | 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). | From randomization to disease progression or death, up to 15 years. |
| Overall survival | 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. | From randomization to death from any cause, up to 15 years. |
| Acute and late toxicity during the study | 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. |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
No clinically or radiologically suspected metastases
Prior lymphadenectomy required
Meets at least 1 of the following criteria for poor prognosis:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Karim Fizazi, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49100 | France | |||
| Hopital Saint Andre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22119204 | Result | 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. | |
| Result | 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. | ||
| Result | 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. |
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| Goserelin Acetate |
| Drug |
|
|
| docetaxel | Drug |
|
| Estramustine phosphate sodium | Drug |
|
| acetylsalicylic acid | Drug |
|
|
| conventional surgery | Procedure |
|
| radiation therapy | Radiation |
|
| Throughout study completion, up to 15 years. |
| Quality of life questionnaire - Core 30 (QLQ-C30) | 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. | At baseline, 3 months, and 1 year |
| 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 | Créteil | 94000 | France |
| Clinique Sainte-Marguerite | Hyères | 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 |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 57038 | France |
| Hopital Clinique Claude Bernard | Metz | 57072 | France |
| Centre Hospitalier General de Mont de Marsan | Mont-de-Marsan | 40000 | France |
| Hopital Lapeyronie-CHU Montpellier | Montpellier | 34295 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Catherine de Sienne | Nantes | 02 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Hopital de la Croix St. Simon | Paris | 75020 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Hopital Saint Joseph | Paris | 75674 | France |
| Hopital Tenon | Paris | 75970 | 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 |
| CRLCC Nantes - Atlantique | Saint-Herblain | 44805 | France |
| Hopital Foch | Suresnes | 92151 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Hospitalier Universitaire Bretonneau de Tours | Tours | 37044 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| 26028518 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D000077143 | Docetaxel |
| D004961 | Estramustine |
| D001241 | Aspirin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D013812 | Therapeutics |
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