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

Prostatic Neoplasms Clinical Trial

Official title:

A Single-arm, International, Prospective, Interventional, Open-label, Multicenter Study of Radium-223 Dichloride in the Treatment of Patients With Castration-Resistant Prostate Cancer (CRPC) With Bone Metastasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810770
• Other study ID #: 15397
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2013
• Est. completion date: September 25, 2017

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: September 25, 2017
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride, 55 kBq/kg body weight, will be administered as a slow bolus IV injection at 4 week intervals for up to 6 doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		Up to 36 months
Primary	Number of participants with laboratory changes		Up to 36 months
Primary	Number of participants with changes in vital signs		Up to 36 months
Primary	Number of participants with changes in electrocardiogram (ECG)		Up to 36 months
Primary	Overall Survival (OS)	OS is defined as the time from date of first study drug treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.	Up to 36 months
Secondary	Changes in total Alkaline Phosphate (ALP) in serum		Up to 36 months
Secondary	Number of participants with total-ALP normalization		Up to 36 months
Secondary	Time to total ALP progression		Up to 36 months
Secondary	Changes in prostate specific antigen (PSA) in serum		Up to 36 months
Secondary	Time to PSA progression		Up to 36 months
Secondary	Time to first skeletal related event (SRE)		Up to 36 months
Secondary	SRE free survival		Up to 36 months
Secondary	Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms		Up to 36 months
Secondary	Time to occurrence of first start of any other anti-cancer treatment		Up to 36 months
Secondary	Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)		Up to 36 months
Secondary	Quality of life (QoL)	QoL is assessed by the scores got from the Functional Assessment of Cancer Therapy in subjects with prostate cancer (FACT-P) questionnaire, EuroQoL (EQ-5D) questionnaire, and the BPI-SF questionnaire.	Up to 36 months
Secondary	Time to pain progression		Up to 36 months

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