Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis

Bayer

Status and phase

Completed

Phase 3

Conditions

Prostatic Neoplasms

Treatments

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01810770

15397

Details and patient eligibility

About

To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.

Enrollment

243 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate
Patients diagnosed with progressive bone predominant metastatic Castration-Resistant Prostate Cancer (CRPC) /Hormone Refractory Prostate Cancer (HRPC) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
Known hormone refractory disease
No intention to use cytotoxic chemotherapy within the next 6 months
Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external bean radiation therapy (EBRT) for bone pain within previous 12 weeks
Age >/= 18 years
Race is Asian
Eastern Co-operative Oncology Group (ECOG) Performance Status (PS): 0-2
Life expectancy >/= 6 months
Adequate bone marrow, liver and renal function as assessed by the Laboratory required by protocol

Exclusion criteria

Treatment with an investigational drug within previous 4 weeks prior to screening, or planned during the treatment or follow-up periods
Eligible for docetaxel treatment, i.e. subjects who are fit enough, willing and who are located where treatment with docetaxel is available
Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to screening (however ongoing neuropathy is permitted)
Prior hemibody external radiotherapy is excluded. Subjects 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 radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
Blood transfusion or erythropoetin stimulating agents within the previous 4 weeks prior to screening
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/pelvic computed tomography (CT) or other imaging modality
Presence of brain metastases
Lymphadenopathy exceeding 3 cm in short-axis diameter
Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered.
Received local practice implant therapy containing lodine-125 or Palladium-103 for the primary lesion of prostate cancer within the 6 months prior to screening.
Any other serious illness or medical condition