Clinical trial NCT01810770: Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Radium-223 Dichloride
Prostatic Neoplasms
Bone Metastasis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 243
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 36 months
measure: Number of participants with laboratory changes
timeFrame: Up to 36 months
measure: Number of participants with changes in vital signs
timeFrame: Up to 36 months
measure: Number of participants with changes in electrocardiogram (ECG)
timeFrame: Up to 36 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Changes in total Alkaline Phosphate (ALP) in serum
timeFrame: Up to 36 months
measure: Number of participants with total-ALP normalization
timeFrame: Up to 36 months
measure: Time to total ALP progression
timeFrame: Up to 36 months
measure: Changes in prostate specific antigen (PSA) in serum
timeFrame: Up to 36 months
measure: Time to PSA progression
timeFrame: Up to 36 months
measure: Time to first skeletal related event (SRE)
timeFrame: Up to 36 months
measure: SRE free survival
timeFrame: Up to 36 months
measure: Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms
timeFrame: Up to 36 months
measure: Time to occurrence of first start of any other anti-cancer treatment
timeFrame: Up to 36 months
measure: Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: Up to 36 months
measure: Quality of life (QoL)
timeFrame: Up to 36 months
measure: Time to pain progression
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Donggu,
country: Korea, Republic of
state: Gwangju Gwang''yeogsi
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Taipei City
country: Taiwan
state: Taipei
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: