A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety
- Conditions
- Prostate Cancer
- Interventions
- Drug: Radium-223-dichloride (Xofigo, BAY88-8223)
- Registration Number
- NCT04681144
- Lead Sponsor
- Bayer
- Brief Summary
The study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. It is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. This type of cancer is called metastatic castration-resistant prostate cancer, also called mCRPC. Sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives.
In this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. The patients in this study will already be receiving treatment with radium-223 as part of their routine care. The tests and measurements in this study will be done by the patients' own doctors. The researchers will collect information about the patients' treatment and results.
The study will include patients with mCRPC who have at least 2 tumors in their bones. These patients will have recently started treatment with radium-223. The patients will have also had surgery or treatment to lower their testosterone levels. But, the treatment did not help their cancer. The study will include about 105 men in Colombia who are at least 18 years old.
All of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. They will visit their doctor's office up to 8 times during 28 weeks. At these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. The doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 103
- Male adult patients (> 18 years)
- Label Xofigo
- Signed informed consent
- No participation in an investigational program with interventions outside of routine clinical practice.
- Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice, as treatment option for mCRPC either as first line (naïve), second line (after progression during treatment with enzalutamide or abiraterone) or third line (post-Docetaxel).
- Patients with contraindications to the use of Radium-223 according to the local label.
- Patients and who refused to sign the informed consent form.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radium-223-dichloride (Xofigo, BAY88-8223) Radium-223-dichloride (Xofigo, BAY88-8223) Patients with metastatic castration-resistant prostate cancer (mCRPC)
- Primary Outcome Measures
Name Time Method Absolute scores for FACT-P At week 28 Absolute scores for EORTC QLQ-PR25 At week 28
- Secondary Outcome Measures
Name Time Method Absolute scores for EORTC QLQ-PR25; according to number of Radium-223 cycles Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Number of cycles of Radium-223 will be measured as total number of doses received.
Absolute scores for FACT-P; according line of treatment Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Line of treatment is classified as first , second or third line agent according to formulation scheme.
Absolute scores for EORTC QLQ-PR25; according to prior use or chemotherapy. Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Patients will be classified as prior chemotherapy or chemotherapy naïve
Absolute scores for FACT-P; according to clinical characteristics. Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) 0-1, more than 2 bone metastasis, no visceral metastasis, Neutrophils: \> 1.500 L (\>1.5 x10exp9/L, Hemoglobin: \> a 10 g/dL, Platelets: \> a 100.000 (\>100x10exp9/L).
Absolute scores for EORTC QLQ-PR25; according to clinical characteristics. Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Clinical characteristics: ECOG 0-1, more than 2 bone metastasis, no visceral metastasis, Neutrophils: \> 1.500 L (\>1.5 x10exp9/L, Hemoglobin: \> a 10 g/dL, Platelets: \> a 100.000 (\>100x10exp9/L).
Absolute scores for FACT-P; according to changes in PSA. Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Prostate specific antigen (PSA) level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (PSA level at week n - PSA level from baseline)/(PSA level from baseline)\*100
Absolute scores for Physical Well Being, Social/Family Well Being, Emotional Well Functional Well Being, in the FACT-P Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Absolute scores for urinary and bowel symptoms, sexual activity and function, and adverse effects to treatments in the EORTC QLQ-PR25 Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Absolute scores for FACT-P; according to number of Radium-223 cycles Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Number of cycles of Radium-223 will be measured as total number of doses received.
Absolute scores for EORTC QLQ-PR25; according line of treatment Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Line of treatment is classified as first , second or third line agent according to formulation scheme.
Absolute scores for FACT-P; according to prior use or chemotherapy Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Patients will be classified as prior chemotherapy or chemotherapy naïve
Absolute scores for EORTC QLQ-PR25; according to changes in PSA Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection PSA level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (PSA level at week n - PSA level from baseline)/(PSA level from baseline)\*100
Absolute scores for FACT-P; according to changes in ALP level Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection Alkaline phosphatase (ALP) level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (ALP level at week n - ALP level from baseline)/(ALP level from baseline)\*100
Absolute scores for EORTC QLQ-PR25; according to changes in ALP level Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection ALP level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (ALP level at week n - ALP level from baseline)/(ALP level from baseline)\*100
Trial Locations
- Locations (1)
Many Locations
🇨🇴Multiple Locations, Colombia
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