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-NO
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-26
• Last Update Posted: 11 December 2017

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:
oThe 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
oIn 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
oAbsolute neutrophil count (ANC) = 1.5 x109/L
oPlatelet count = 100 x109/L
oHemoglobin =10.0 g/dL (100 g/L; 6.2 mmol/L)
oTotal bilirubin level = 1.5 x institutional upper limit of normal (ULN)
oAspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
oCreatinine = 1.5 x ULN
oAlbumin > 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:
oAny infection = NCI-CTCAE v.4.03 Grade 2
oCardiac failure New York Heart Association (NYHA) III or IV
oCrohn’s disease or ulcerative colitis
oBone 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<br><br>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 on-ward);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.<br>During the treatment period, patients will be evaluated<br>at each visit, prior to receiving Ra-223 Cl.<br>During the follow-up period, patients will be evaluated every 6 months for long-term safety.