check_circleStudy Completed

Prostatic Neoplasms

Bayer Identifier:

15397

ClinicalTrials.gov Identifier:

NCT01810770

EudraCT Number:

Not Available

EU CT Number:

Not Available
Radium-223 dichloride Asian population study in the treatment of CRPC patients with bone metastasis

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
243
Trial Dates
March 2013 - September 2017
Phase
Phase 3
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Singapore, 169610, Singapore
Completed
Singapore, 258499, Singapore
Completed
Singapore, 119228, Singapore
Completed
Singapore, Singapore
Completed
Taipei, 10002, Taiwan
Completed
Taoyuan, 333, Taiwan
Completed
Taipei City, 112, Taiwan
Completed
Kaohsiung, 81362, Taiwan
Completed
Seoul, 05505, Korea, Republic Of
Completed
Seoul, 03080, Korea, Republic Of
Completed
Donggu,, 61469, Korea, Republic Of
Completed
Seoul, 06351, Korea, Republic Of
Completed
Shanghai, 200433, China
Withdrawn
Beijing, 100191, China
Withdrawn
Beijing, 100034, China
Completed
Beijing, 100730, China
Withdrawn
shanghai, 200032, China
Completed
Shanghai, 200032, China
Completed
Guangzhou, China
Completed
Shanghai, 200127, China
Completed
Shanghai, 200072, China
Completed
Beijing, 100029, China
Completed
Guangzhou, 510060, China
Completed
Beijing, 100021, China
Completed
Nanjing, 210008, China
Completed
Nanjing, 210009, China
Completed
Beijing, 100050, China
Completed
Shanghai, 200040, China
Completed
Beijing, 100020, China
Completed
Guangzhou, 510080, China

Primary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with laboratory changes
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with changes in vital signs
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with changes in electrocardiogram (ECG)
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Changes in total Alkaline Phosphate (ALP) in serum
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with total-ALP normalization
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to total ALP progression
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Changes in prostate specific antigen (PSA) in serum
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to PSA progression
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to first skeletal related event (SRE)
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • SRE free survival
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to occurrence of first start of any other anti-cancer treatment
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to pain progression
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

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