Asymptomatic or mildly symptomatic chemotherapy-naïve bone predominant metastatic castration-resistant prostate cancer MedDRA version: 16.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed adenocarcinoma of the prostate - 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. - Subjects who received combined androgen blockade with an anti-androgen must have shown PSA 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: - 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. - Pathological finding consistent with small cell carcinoma of the prostate - History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations - History of or known brain metastasis. - Malignant lymphadenopathy exceeding 3 cm in shortaxis diameter. - Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the clinical benefit of radium-223 dichloride versus placebo in combination with abiraterone and prednisone/prednisolone in asymptomatic or mildly symptomatic chemotherapynaïve bone predominant metastatic castration-resistant prostate cancer patients.;Secondary Objective: The secondary objectives are to compare overal survival, time to opiate use for cancer pain, time to pain progression, time to cytotoxic chemotherapy, radiological progression free survival, acute and long term safety.;Primary end point(s): Symptomatic skeletal event free survival(SSE-FS);Timepoint(s) of evaluation of this end point: At 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall Survival 2. Time to opiate use for cancer pain 3. Time to pain progression 4. Time to cytotoxic chemotherapy 5. Radiological progression free survival (rPFS) 6. Number of participants with adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: 1. At 3 years for interim At 6 years for final 2. At 3 years 3. At 3 years 4. At 3 years 5. At 3 years 6. Up to 3 years | — |
Countries
Australia, Belgium, Brazil, Canada, China, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed