Study 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

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

Trial summary

Enrollment Goal

243

Trial Dates

March 2013 - September 2017

Phase

Phase 3

Could I Receive a placebo

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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
Time Frame:
Up to 36 months
Safety Issue:
Yes
Number of participants with laboratory changes
Time Frame:
Up to 36 months
Safety Issue:
Yes
Number of participants with changes in vital signs
Time Frame:
Up to 36 months
Safety Issue:
Yes
Number of participants with changes in electrocardiogram (ECG)
Time Frame:
Up to 36 months
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.
Time Frame:
Up to 36 months
Safety Issue:
No

Secondary Outcome

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

Additional Information

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