Radium-223 Chloride in the treatment patients diagnosed with prostate cancer that has spread to the bone

Phase 1

Conditions: Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasis
MedDRA 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-ES

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1925

Inclusion Criteria

- 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:
o 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
o 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:
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

Exclusion Criteria

? 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 non-melanoma 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