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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01810770

Collaborator

(none)

243

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Radium-223 dichloride (Xofigo, BAY88-8223)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

243 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Mar 26, 2013

Actual Primary Completion Date :

Sep 25, 2017

Actual Study Completion Date :

Sep 25, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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) [Up to 36 months]
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.

Secondary Outcome Measures

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) [Up to 36 months]
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.
Time to pain progression [Up to 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Guangzhou	Guangdong	China	510060
2	Guangzhou	Guangdong	China	510080
3	Nanjing	Jiangsu	China	210008
4	Nanjing	Jiangsu	China	210009
5	Beijing		China	100020
6	Beijing		China	100021
7	Beijing		China	100029
8	Beijing		China	100050
9	Beijing		China	100730
10	Guangzhou		China
11	Shanghai		China	200032
12	Shanghai		China	200040
13	Shanghai		China	200072
14	Shanghai		China	200127
15	Shanghai		China	200433
16	Donggu,	Gwangju Gwang''yeogsi	Korea, Republic of	61469
17	Seoul		Korea, Republic of	03080
18	Seoul		Korea, Republic of	05505
19	Seoul		Korea, Republic of	06351
20	Singapore		Singapore	119228
21	Singapore		Singapore	169610
22	Singapore		Singapore	258499
23	Singapore		Singapore
24	Taipei City	Taipei	Taiwan	112
25	Kaohsiung		Taiwan	81362
26	Taipei		Taiwan	10002
27	Taoyuan		Taiwan	333