Radium-223 Chloride in the treatment patients diagnosed with prostate cancer that has spread to the bone
- Conditions
- Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasisMedDRA version: 14.1Level: LLTClassification code 10036916Term: Prostate cancer stage DSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000075-16-IT
- Lead Sponsor
- BAYER HEALTHCARE AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1925
- Has provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the any trial- specific procedure. • Age = 18 years • Histologically or cytologically confirmed prostate cancer • Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed) • Progressive disease is defined either by: - The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; OR - In the absence of a new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA =5 ng/mL • Life expectancy = 6 months • ECOG PS 0-2 • Adequate hematological, liver and renal function o Absolute neutrophil count (ANC) = 1.5 x109/L o Platelet count = 100 x109/L o Hemoglobin =10.0 g/dL (100 g/L; 6.2 mmol/L) o Total bilirubin level = 1.5 x institutional upper limit of normal (ULN) o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN o Creatinine = 1.5 x ULN o Albumin > 25 g/L • Willing and able to comply with the protocol, including follow-up visits and examinations
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 925
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000
• Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up • Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available • Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted) • Received previous radiotherapy to approximately > 25% of bone marrow, including hemibody radiation • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases • Other malignancy treated within the last 3 years (except nonmelanoma skin cancer or low-grade superficial bladder cancer) • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality • Presence of brain metastases • Lymphadenopathy exceeding 6 cm in short-axis diameter • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis. • Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI) • Any other serious illness or medical condition, such as but not limited to: o Any infection = NCI-CTCAE v.4.03 Grade 2 o Cardiac failure New York Heart Association (NYHA) III or IV o Crohn's disease or ulcerative colitis o Bone marrow dysplasia • Fecal incontinence
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Provide radium-223 chloride to patients diagnosed with CRPC/HRPC with bone metastasis - To assess acute and long-term safety of radium-223 chloride;Secondary Objective: not applicable;Primary end point(s): Acute (during treatment and up to 30 days last treatment) and Long- Term Safety (30 days last treatment and onward);Timepoint(s) of evaluation of this end point: During treatment and follow-up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Upon obtaining signed informed consent, obtain baseline safety data. During the treatment period, patients will be evaluated at each visit, prior to receiving Ra-223 Cl. During the follow-up period, patients will be evaluated every 6 months for long-term safety