Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01810770
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
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 : March 26, 2013
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : September 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 36 months ]
  2. Number of participants with laboratory changes [ Time Frame: Up to 36 months ]
  3. Number of participants with changes in vital signs [ Time Frame: Up to 36 months ]
  4. Number of participants with changes in electrocardiogram (ECG) [ Time Frame: Up to 36 months ]
  5. Overall Survival (OS) [ Time Frame: 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 :
  1. Changes in total Alkaline Phosphate (ALP) in serum [ Time Frame: Up to 36 months ]
  2. Number of participants with total-ALP normalization [ Time Frame: Up to 36 months ]
  3. Time to total ALP progression [ Time Frame: Up to 36 months ]
  4. Changes in prostate specific antigen (PSA) in serum [ Time Frame: Up to 36 months ]
  5. Time to PSA progression [ Time Frame: Up to 36 months ]
  6. Time to first skeletal related event (SRE) [ Time Frame: Up to 36 months ]
  7. SRE free survival [ Time Frame: Up to 36 months ]
  8. Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms [ Time Frame: Up to 36 months ]
  9. Time to occurrence of first start of any other anti-cancer treatment [ Time Frame: Up to 36 months ]
  10. Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: Up to 36 months ]
  11. Quality of life (QoL) [ Time Frame: 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.

  12. Time to pain progression [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810770


Locations
Layout table for location information
China, Guangdong
Guangzhou, Guangdong, China, 510060
Guangzhou, Guangdong, China, 510080
China, Jiangsu
Nanjing, Jiangsu, China, 210008
Nanjing, Jiangsu, China, 210009
China
Beijing, China, 100020
Beijing, China, 100021
Beijing, China, 100029
Beijing, China, 100050
Beijing, China, 100730
Guangzhou, China
Shanghai, China, 200032
Shanghai, China, 200040
Shanghai, China, 200072
Shanghai, China, 200127
Shanghai, China, 200433
Korea, Republic of
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Singapore
Singapore, Singapore, 119228
Singapore, Singapore, 169610
Singapore, Singapore, 258499
Singapore, Singapore
Taiwan
Taipei City, Taipei, Taiwan, 112
Kaohsiung, Taiwan, 81362
Taipei, Taiwan, 10002
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01810770     History of Changes
Other Study ID Numbers: 15397
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Radium-223 Dichloride
Prostatic Neoplasms
Bone Metastasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents