Clinical trial NCT04681144: 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
Official title: Describing the Quality Of Life in Colombian Patients mCRPC Under Treatment With RADium-223.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Bone metastatic castration resistant prostate cancer
Radium-223
mCRPC
Phase IV
Advance prostate cancer
Quality of life
Bone Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 103
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colombian patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC).

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Patients with contraindications to the use of Radium-223 according to the local label.
* Patients and who refused to sign the informed consent form.

Primary outcomes:
measure: Absolute scores for FACT-P
timeFrame: At baseline
measure: Absolute scores for FACT-P
timeFrame: At week 12
measure: Absolute scores for FACT-P
timeFrame: At week 16
measure: Absolute scores for FACT-P
timeFrame: At week 24
measure: Absolute scores for FACT-P
timeFrame: At week 28
measure: Absolute scores for EORTC QLQ-PR25
timeFrame: At baseline
measure: Absolute scores for EORTC QLQ-PR25
timeFrame: At week 12
measure: Absolute scores for EORTC QLQ-PR25
timeFrame: At week 16
measure: Absolute scores for EORTC QLQ-PR25
timeFrame: At week 24
measure: Absolute scores for EORTC QLQ-PR25
timeFrame: At week 28
Secondary outcomes:
measure: Absolute scores for Physical Well Being, Social/Family Well Being, Emotional Well Functional Well Being, in the FACT-P
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for urinary and bowel symptoms, sexual activity and function, and adverse effects to treatments in the EORTC QLQ-PR25
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for FACT-P; according to number of Radium-223 cycles
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for EORTC QLQ-PR25; according to number of Radium-223 cycles
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for FACT-P; according line of treatment
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for EORTC QLQ-PR25; according line of treatment
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for FACT-P; according to prior use or chemotherapy
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for EORTC QLQ-PR25; according to prior use or chemotherapy.
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for FACT-P; according to clinical characteristics.
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for EORTC QLQ-PR25; according to clinical characteristics.
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for FACT-P; according to changes in PSA.
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for EORTC QLQ-PR25; according to changes in PSA
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for FACT-P; according to changes in ALP level
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
measure: Absolute scores for EORTC QLQ-PR25; according to changes in ALP level
timeFrame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
Other outcomes:
Locations:
city: Multiple Locations
country: Colombia
facility: Many Locations
Study officials:
References: