A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer


Condition: Metastatic Prostate Cancer

Intervention:

  • Drug: abiraterone acetate
  • Radiation: radiotherapy
  • Other: Androgen Deprivation Therapy
  • Drug: Docetaxel

Purpose: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy (+ docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01957436

Sponsor: UNICANCER

Primary Outcome Measures:

  • Measure: Survival
  • Time Frame: 5.5 years after the first inclusion
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: PSA response rate
  • Time Frame: 8 months
  • Safety Issue:
  • Measure: Prospective correlative study of PSA response/progression
  • Time Frame: 8 months
  • Safety Issue:
  • Measure: Prostate cancer specific survival
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: Time to pain progression
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: Time to next skeletal-related event
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: Time to chemotherapy
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: Time to severe local symptoms
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: Toxicity of the study treatment
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: The radiological progression-free survival
  • Time Frame: 5.5 years
  • Safety Issue:
  • Measure: Impact of radiotherapy protocol on outcome
  • Time Frame: 5.5 years
  • Safety Issue:

Estimated Enrollment: 1168

Study Start Date: November 13, 2013

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed adenocarcinoma of the prostate, 2. Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes can be included if they have either:
  • At least one extra-pelvic lymph node ≥ 2 cm or
  • extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm 3. Patients with ECOG ≤ 1 (PS 2 due to bone pain accepted), 4. Life expectancy ≥ 6 months, 5. Male aged ≥ 18 years old, 6. Hemoglobin ≥ 10.0 g/dL, 7. Platelet count ≥ 100,000/μL, 8. Serum creatinine < 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min, 9. Serum potassium ≥ 4.0 mmol/L, 10. Serum bilirubin ≤ 1.5 x ULN (except documented Gilbert's disease); AST and ALT ≤ 1.5 x ULN (≤ 5 ULN in case of liver metastases), ALP ≤ 2.5 x ULN 11. Patients might have received a maximum of 3 months of ADT before randomization, 12. Patients might have received previous radiation therapy directed to bone lesions 13. Patients able to take oral medication, 14. Patients who have received the information sheet and signed the informed consent form, 15. Male patients who are receiving the study treatment and have partners of childbearing potential are advised to use a method of birth control with adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment. 16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, 17. Patients with a public or a private health insurance coverage, 18. Patients willing to receive docetaxel 19. Neutrophil ≥ 1500 cells/mm3 20. Male patients who have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of docetaxel.

Exclusion Criteria:

  1. Patients with previous local treatment directed to the prostate primary cancer. A previous TURP is allowed,
  2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
  3. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
  4. Active infection or other medical condition for which corticosteroid use would be contraindicated,
  5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
  6. Prior systemic treatment with an azole drug within 4 weeks of randomization,
  7. Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg),
  8. Patients with a history of hypertension except if blood pressure is controlled by anti-hypertensive treatment,
  9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
  10. History of pituitary or adrenal dysfunction,
  11. Small cell carcinoma of the prostate,
  12. Clinically known significant heart disease (myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina,NYHA Class II-IV heart disease or cardiac EF < 50% at baseline,
  13. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
  14. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
  15. Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
  16. Administration of an investigational therapeutic within 30 days of D1,
  17. Patients already included in another therapeutic trial involving an experimental drug,
  18. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering participation,
  19. Individual deprived of liberty or placed under the authority of a tutor. Additional criteria for patients receiving docetaxel:
  20. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.
  21. Concomitant use of strong CYP3A4 inhibitors ( clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)
  22. Allergy to taxane

Contact:

  • Beata JUZYNA

Locations:

  • Onze Lieve Vrouw Ziekenhuis
  • Aalst Belgium
  • Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet
  • Brussels Belgium
  • Hopital de Jolimont
  • Haine Saint Paul Belgium
  • AZ Groeninge Kortrijk - Campus Vercruysselaan
  • Kortrijk Belgium
  • Cliniques Universitaires Saint Luc
  • Louvain Belgium
  • Cliniques Universitaires Saint-Luc
  • Louvain Belgium
  • Centre Radiotherapie Oncologie Moyenne Garonne-CROMG
  • Agen France
  • Clinique Claude Bernard
  • Albi 81000 France
  • Clinique de L'Europe
  • Amiens France
  • Institut de cancerologie de l'Ouest
  • ANGERS Cedex 9 49933 France
  • Clinique Générale d'Annecy
  • Annecy 74000 France
  • Centre Marie Curie
  • Arras France
  • Institut Sainte Catherine
  • Avignon Cedex 9 84918 France
  • Centre de la Baie
  • Avranches France
  • Centre d'Oncologie et de Radiothérapie du Pays Basque
  • Bayonne 64100 France
  • Chu Jean Minjoz
  • Besancon 25030 France
  • Centre Pierre Curie
  • Beuvry France
  • Institut Bergonie
  • Bordeaux 33076 France
  • Clinique Pasteur
  • Brest 29200 France
  • Centre François Baclesse
  • Caen France
  • Centre Hospitalier Alpes Leman
  • Contamine Sur Arve 74130 France
  • SERA
  • Contamine Sur Arve 74130 France
  • Chu de Mondor
  • Creteil 94010 France
  • Centre Leonard de Vinci
  • Dechy France
  • Centre Georges-François LECLERC
  • Dijon 21079 France
  • Clinique Sainte Marguerite
  • Hyères 83400 France
  • CHD Vendée
  • La ROCHE sur YON 85925 France
  • Clinique Victor Hugo
  • Le Mans 72000 France
  • Chu de Limoges
  • Limoges 87042 France
  • Centre Léon Bérard
  • Lyon cedex 08 69373 France
  • CHU Lyon Sud
  • Lyon France
  • Chu Timone
  • MARSEILLE Cedex 5 13385 France
  • Institut Paoli Calmettes
  • Marseille 13273 France
  • Hôpital Nord
  • Marseille France
  • Groupe Hospitalier Intercommunal Le Raincy Montfermeil
  • Montfermeil France
  • Centre Azuréen de Cancérologie
  • Mougins 06250 France
  • Centre de Radiothérapie de Macon
  • Mâcon France
  • Centre Catherine de Sienne
  • Nantes Cedex 2 44202 France
  • Centre Antoine Lacassagne
  • Nice 06189 France
  • CHU Carémeau
  • NIMES Cedex 9 30029 France
  • CHR Orléans la source
  • Orleans 45100 France
  • Institut Curie
  • Paris 75005 France
  • Hôpital St Louis
  • Paris 75010 France
  • Hopital TENON
  • Paris France
  • Chic Quimper
  • Quimper 29107 France
  • Centre Eugène Marquis
  • RENNES Cedex 35042 France
  • Centre de Radiothérapie CROM et d'Oncologie Medical de L'Essonne
  • Ris-Orangis France
  • Chu de Rouen
  • Rouen 76031 France
  • Clinique Armoricaine de radiologie
  • Saint Brieuc 22015 France
  • CHU ST ETIENNE - Hôpital Nord
  • Saint Etienne 44270 France
  • CHP Saint Grégoire
  • Saint Gregoire 35760 France
  • Institut de Cancérologie del'Ouest - site René Gauducheau
  • Saint-herblain 44805 France
  • CENTRE DE CANCEROLOGIE Paris Nord
  • Sarcelles France
  • Institut de Cancérologie Lucien Neuwirth
  • St PRIEST EN JAREZ 42271 France
  • Strasbourg Oncologie Libérale
  • Strasbourg 67000 France
  • Hopitaux du Leman
  • Thonon-les-bains 74203 France
  • Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse
  • Toulon 83056 France
  • Clinique Pasteur
  • TOULOUSE Cedex 3 31076 France
  • Institut Claudius Regaud
  • TOULOUSE Cedex 31052 France
  • CHU de TOURS Hôpital Bretonneau
  • Tours France
  • Centre d'Oncologie Saint Yves
  • Vannes France
  • INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris
  • Villejuif 94805 France
  • Universitäts-klinikum Freiburg
  • Freiburg Germany
  • Gesundheitszentrum Holzminden
  • Holzminden Germany
  • Cork University Hospital
  • Cork Ireland
  • Adelaide and Meath incorporating National Children's hospital department
  • Dublin Ireland
  • Mater Misericordiae University Hospital
  • Dublin Ireland
  • Mater Private Hospital
  • Dublin Ireland
  • St Vincent's University Hospital
  • Dublin Ireland
  • Galway University Hospital
  • Galway Ireland
  • Università di Brescia - Sistema Socio Sanitaria Territoriale, ASST Spedali civili Brescia
  • Brescia Italy
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Meldola Italy
  • San Camillo Forlanini Hospitals
  • Roma Italy
  • 'Hospital Bestriz angelo
  • Loures Portugal
  • 'Instituto Portugues de Oncologia do Porto Francisco Gentil, E,P,E
  • Porto Portugal
  • Sc Radiotherapy Center Cluj SRL
  • Cluj Romania
  • Hospital Germans Trias i Pujol
  • Badalona Spain
  • Hospital De la Santa Creu I Sant Pau
  • Barcelona Spain
  • Hospital del Mar
  • Barcelona Spain
  • Vall d'Hebron University Hospital
  • Barcelona Spain
  • ICO Girona - Hospital Josep Trueta
  • Girona Spain
  • Hospital Universitario Lucus Augusti
  • Lugo Spain
  • Hospital 12 OCTUBRE
  • Madrid Spain
  • Hospital Universitario HM Sanchinarro
  • Madrid Spain
  • Althaia
  • Manresa Spain
  • 'Hospital Clinico Virgen de la Victoria
  • Málaga Spain
  • 'Parc Tauli Sabadell Hospital Universitari
  • Sabadell Spain
  • Hospital Universitario de Salamanca
  • Salamanca Spain
  • Institut Valenciano de Oncologia
  • Valencia Spain
  • Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti
  • Geneva Switzerland
  • Centre Hospitalier Universitaire Vaudois
  • Lausanne Switzerland

View trial on ClinicalTrials.gov


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