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

• Register: EUCTR
• Last refreshed on: 11 December 2017
• Main ID: EUCTR2012-000075-16-NO
• Date of registration: 26/04/2012
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: Radium-223 Chloride in the treatment patients diagnosed with prostate cancer that has spread to the bone
• Scientific title: Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
• Date of first enrolment: 14/06/2013
• Target sample size: 1925
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000075-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Bayer Clin Trials, Contact CTP Team
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clin Trials, Contact CTP Team
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasis
MedDRA version: 14.1 Level: LLT Classification code 10036916 Term: Prostate cancer stage D System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Radium-223 chloride
Product Code: BAY88-8223
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Radium-223 chloride
CAS Number: 444811-40-9
Current Sponsor code: BAY88-8223
Concentration unit: kBq/ml kilobecquerel(s)/millilitre
Concentration type: equal
Concentration number: 1000 at ref. date-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: During treatment and follow-up

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)

Secondary Objective: Not applicable

Secondary Outcome(s)

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.

Secondary ID(s)

2012-000075-16-SE

BAY88-8223/16216

Source(s) of Monetary Support

Bayer HealthCare AG