Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatment radium-223 dichloride (xofigo, bay88-8223)
Phase phase 3
Sponsor Bayer
Start date March 2013
End date September 2017
Trial size 244 participants
Trial identifier NCT01810770, 15397

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: Up to 36 months
Number of participants with laboratory changes
time frame: Up to 36 months
Number of participants with changes in vital signs
time frame: Up to 36 months
Number of participants with changes in electrocardiogram (ECG)
time frame: Up to 36 months
Overall Survival (OS)
time frame: Up to 36 months

Secondary Outcomes

Measure
Changes in total Alkaline Phosphate (ALP) in serum
time frame: Up to 36 months
Number of participants with total-ALP normalization
time frame: Up to 36 months
Time to total ALP progression
time frame: Up to 36 months
Changes in prostate specific antigen (PSA) in serum
time frame: Up to 36 months
Time to PSA progression
time frame: Up to 36 months
Time to first skeletal related event (SRE)
time frame: Up to 36 months
SRE free survival
time frame: Up to 36 months
Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms
time frame: Up to 36 months
Time to occurrence of first start of any other anti-cancer treatment
time frame: Up to 36 months
Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
time frame: Up to 36 months
Quality of life (QoL)
time frame: Up to 36 months
Time to pain progression
time frame: Up to 36 months

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.