| Titre |
A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer |
| Protocole ID |
15396 |
| ClinicalTrials.gov ID |
NCT02043678 |
| Type(s) de cancer |
Prostate |
| Phase |
Phase III |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
 HOPITAL NOTRE-DAME
1560 rue Sherbrooke Est, Montréal, QC, H2L 4M1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Fred Saad
|
| Coordonnateur(trice) |
Brigitte Brisson
514-890-8000 poste 26074
Virginie Decamps
514-890-8000 x28417
|
| Statut |
![]() Fermé |
| Date d'activation |
10-12-2014 |
| Critètes d'éligibilité |
-
Histologically or cytologically confirmed adenocarcinoma of the prostate
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Male subjects of age ≥ 18 years
-
Prostate cancer progression documented by prostate specific antigen according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
-
Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis.
-
Asymptomatic or mildly symptomatic prostate cancer.
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Subjects who received combined androgen blockade with an anti-androgen must have shown PSA(prostate specific antigen) progression after discontinuing the anti-androgen prior to enrollment.
-
Medical or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L).
-
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
|
| Critètes d'exclusion |
-
Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
-
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
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Pathological finding consistent with small cell carcinoma of the prostate
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History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
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History of or known brain metastasis.
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Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
-
Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
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Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered
-
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.
|
Groupe d'étude en oncologie du Québec