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

NCT01810770 | Completed Phase 3

• 1 other identifier: 15397
• Study Type: interventional
• Target: 243
• Locations: 4 countries
• Sites: 27

Brief 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.

Conditions

Prostatic Neoplasms

Keywords

Radium-223 Dichloride; Prostatic Neoplasms; Bone Metastasis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• 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

Study Arms (1)

Radium-223 dichloride

EXPERIMENTAL

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

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223) DRUG

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.

Radium-223 dichloride

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (27)

Unknown Facility

Guangzhou, Guangdong, 510060, China

Location

Unknown Facility

Guangzhou, Guangdong, 510080, China

Location

Unknown Facility

Nanjing, Jiangsu, 210008, China

Location

Unknown Facility

Nanjing, Jiangsu, 210009, China

Location

Unknown Facility

Beijing, 100020, China

Location

Unknown Facility

Beijing, 100021, China

Location

Unknown Facility

Beijing, 100029, China

Location

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 100730, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Unknown Facility

Shanghai, 200072, China

Location

Unknown Facility

Shanghai, 200127, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Singapore, 119228, Singapore

Location

Unknown Facility

Singapore, 169610, Singapore

Location

Unknown Facility

Singapore, 258499, Singapore

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Donggu, Gwangju Gwang''yeogsi, 61469, South Korea

Location

Unknown Facility

Seoul, 03080, South Korea

Location

Unknown Facility

Seoul, 05505, South Korea

Location

Unknown Facility

Seoul, 06351, South Korea

Location

Unknown Facility

Taipei City, Taipei, 112, Taiwan

Location

Unknown Facility

Kaohsiung City, 81362, Taiwan

Location

Unknown Facility

Taipei, 10002, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

Related Links

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: March 26, 2013
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

CN (15); SG (4); KR (4); TW (4)