Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Belgium / NCT01957436
Active, not recruiting Phase 3

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

NCT01957436 · tracked via the Priya Life Science Belgium tracker
Sponsor
Phase
Phase 3
Started
2013-11-13
Last updated
2024-11-12

Condition(s) studied

Metastatic Prostate Cancer

Investigational drug(s) / intervention(s)

abiraterone acetate →radiotherapyAndrogen Deprivation TherapyDocetaxel →

abiraterone acetate: abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid

radiotherapy: 74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)

Androgen Deprivation Therapy: The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy

Docetaxel: 6 cycles at 75mg/m²/cycle, one cycle every 3 weeks

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate, 2. Metastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either: o 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 (patient with PS 2 due to bone pain can be accrued in the trial), 4. Life expectancy of at least 6 months, 5. Male aged ≥ 18 years old and ≤ 80 years old , 6. Hematology values: * Hemoglobin ≥ 10.0 g/dL, * Platelet count ≥ 100,000/mL, * Neutrophil ≥ 1500 cells/mm³ 7. Biochemistry values: * Renal function: Serum creatinine \< 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min, * Serum potassium ≥ 4 mmol/L, * Liver function: * Serum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease), * AST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases), * ALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P\<1000U/L if bilirubin is normal) 8. Patients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel, 9. Patients willing and clinically fit to receive Docetaxel which is defined by the following : * Patients respecting all inclusion and exclusion criteria And * Patients with no contraindication to docetaxel according to the SmPC of the drug And * Patients presenting all medical requirements to receive docetaxel according to the investigator's opinion. 10. Patients might have received previous radiation therapy directed to bone lesions, 11. Patients able to take oral medication, 12. Patients who have received the information sheet and signed the informed consent form, 13. Male patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must 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 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel 14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, 15. Patients with a public or a private health insurance coverage, according to local laws for participation in clinical trials. Exclusion Criteria: 1. Patients with previous definitive local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are 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 5 mg prednisone/prednisolone twice daily, 4. Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contra-indicated, 5. Previously treated with ketoconazole for prostate cancer for more than 7 days, 6. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization, 7. Hypertension not controlled by an anti-hypertensive treatment (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart), 8. Severe or moderate hepatic impairment (Child - Pugh class C or B) 9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease), 10. History of pituitary or adrenal dysfunction, 11. Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline, 12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy, 13. Patient with unstable pulmonary disease (eg. Pulmonary embolism) 14. Pathological finding consistent with small cell carcinoma of the prostate, 15. History of malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months, 16. Known allergies, hypersensitivity or intolerance to the study drugs or excipients or docetaxel 17. Administration of an investigational therapeutic within 30 days of randomization, 18. Patients already included in another therapeutic trial involving an experimental drug (patient in a non-experimental trial with no modification of the patient's care can be included), 19. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial, 20. Individual deprived of liberty or placed under the authority of a tutor. 21. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. Patients with Cystoid Macular Oedema cannot be included due to a potential risk of deterioration associated with docetaxel. 22. Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)

Primary outcome measure(s)

Trial sites (77)

FacilityCityRegionStatus
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 Leuven Belgium
U.Z. Leuven - Campus Gasthuisberg Leuven Belgium
Clinique Claude Bernard Albi France
Institut de cancerologie de l'Ouest Angers France
Clinique Générale d'Annecy Annecy France
Institut Sainte Catherine Avignon France
Centre de la Baie Avranches France
Centre d'Oncologie et de Radiothérapie du Pays Basque Bayonne France
Chu Jean Minjoz Besançon France
Centre Pierre Curie Beuvry France
Institut Bergonie Bordeaux France
Centre François Baclesse Caen France
Centre Hospitalier Alpes Leman Contamine-sur-Arve France
Chu de Mondor Créteil France
Centre Leonard de Vinci Dechy France
Centre Georges-François LECLERC Dijon France
Clinique Sainte Marguerite Hyères France
CHD Vendée La Roche-sur-Yon France
Clinique Victor Hugo Le Mans France
Chu de Limoges Limoges France
Centre Léon Bérard Lyon France
CHU Lyon Sud Lyon France
Institut Paoli Calmettes Marseille France
Chu Timone Marseille France
Hôpital Nord Marseille France
Centre Azuréen de Cancérologie Mougins France
Centre Catherine de Sienne Nantes France
Centre Antoine Lacassagne Nice France
CHU Carémeau Nîmes France
CHR Orléans la source Orléans France
Institut Curie Paris France
Hôpital St Louis Paris France
Hopital TENON Paris France
Chic Quimper Quimper France
Institut Jean Godinot Reims France
Centre Eugène Marquis Rennes France

+ 37 more sites — see the full list on the official registry below.

More UNICANCER trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01957436 on ClinicalTrials.gov ↗ ← All trials in Belgium