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Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Phase 3
18 Years
Open (Enrolling)
Prostatic Neoplasms

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Trial Information

Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Inclusion Criteria:

- Age ≥18 years of age

- Histologically or cytologically confirmed prostate cancer

- Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone
refractory prostate cancer / Castrate resistant prostate cancer) with at least 2
skeletal metastases on imaging 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
imaging only without an increase in prostate specific antigen (PSA), PSA values
from 3 assessments within the last 6 months must be provided; OR

- In the absence of new bone lesions by 2 subsequent 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. (The
reference value time point 1, is defined as the last PSA measured before
increases are documented, with subsequent values obtained a minimum of 1 week
apart. If the PSA at time point 3 is greater than the PSA at time point 2, then
eligibility has been met. If the PSA at time point 3 is not greater than the PSA
at time point 2 but the PSA value at time point 4 and/or time point 5 is greater
than the PSA at time point 2, the patient is eligible assuming that other
criteria are met)

- Life expectancy ≥ 6 months

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2

- Adequate hematological, liver, and renal function

- Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L

- Platelet count ≥ 100 x10^9/L

- Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)

- Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

- Creatinine ≤ 1.5 x ULN

- Albumin > 25 g/L

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 (adverse events) due to cytotoxic chemotherapy administered more than 4
weeks previous (however, ongoing neuropathy is permitted)

- Prior hemibody external radiotherapy is excluded. Patients who received other types
of prior external radiotherapy are allowed provided that the bone marrow function is
assessed and meets the protocol requirements for hemoglobin, absolute neutrophil
count and platelets

- Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153,
rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony

- 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 based on institutional standard of care)

- 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

- Imminent or history of spinal cord compression based on clinical findings and/or
magnetic resonance imaging (MRI). Patients with history of spinal cord compression
should have completely recovered.

- Any other serious illness or medical condition, such as but not limited to:

- Any infection ≥ National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI-CTCAE) version 4.03 Grade 2

- Cardiac failure New York Heart Association (NYHA) III or IV

- Crohn's disease or ulcerative colitis

- Bone marrow dysplasia

- Fecal incontinence

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute safety, variables will be summarized using descriptive statistics based on adverse events collection

Outcome Description:

Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry

Outcome Time Frame:

From baseline to 30 days post-treatment

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

July 2012

Completion Date:

April 2015

Related Keywords:

  • Prostatic Neoplasms
  • Radium 223
  • Alpharadin
  • Prostate Cancer
  • Bone metastases
  • Castrate resistant prostate cancer
  • Hormone refractory prostate cancer
  • Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases