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

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.

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
  • Beijing, China, 100730
  • Beijing, China, 100020
  • Beijing, China, 100029
  • Beijing, China, 100021
  • Guangzhou, China
  • Shanghai, China, 200032
  • Shanghai, China, 200127
  • Shanghai, China, 200040
  • Shanghai, China, 200433
  • Shanghai, China, 200072
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
    • Guangzhou, Guangdong, China, 510060
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
    • Nanjing, Jiangsu, China, 210009
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
  • Seoul, Korea, Republic of, 05505
  • Seoul, Korea, Republic of, 06351
  • Gwangju Gwang''yeogsi
    • Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
• Singapore
  • Singapore, Singapore, 119228
  • Singapore, Singapore
  • Singapore, Singapore, 169610
  • Singapore, Singapore, 258499
• Taiwan
  • Kaohsiung, Taiwan, 81362
  • Taipei, Taiwan, 10002
  • Taoyuan, Taiwan, 333
  • Taipei
    • Taipei City, Taipei, Taiwan, 112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radium-223 dichloride	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability		Up to 36 months
Number of participants with laboratory changes		Up to 36 months
Number of participants with changes in vital signs		Up to 36 months
Number of participants with changes in electrocardiogram (ECG)		Up to 36 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in total Alkaline Phosphate (ALP) in serum		Up to 36 months
Number of participants with total-ALP normalization		Up to 36 months
Time to total ALP progression		Up to 36 months
Changes in prostate specific antigen (PSA) in serum		Up to 36 months
Time to PSA progression		Up to 36 months
Time to first skeletal related event (SRE)		Up to 36 months
SRE free survival		Up to 36 months
Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms		Up to 36 months
Time to occurrence of first start of any other anti-cancer treatment		Up to 36 months
Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)		Up to 36 months
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
Time to pain progression		Up to 36 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2013
• Primary Completion (Actual): September 25, 2017
• Study Completion (Actual): September 25, 2017

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 14, 2013

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Bone Metastasis; Prostatic Neoplasms; Radium-223 Dichloride
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Prostatic Neoplasms; Neoplasm Metastasis; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 15397

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No