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

NCT04681144 | Completed

• 1 other identifier: 21517
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Bone metastatic castration resistant prostate cancer; Radium-223; mCRPC; Phase IV; Advance prostate cancer; Quality of life; Bone Cancer

Outcome Measures

Primary Outcomes (10)

• Absolute scores for FACT-P

  Functional Assessment of Cancer Therapy-Prostate (FACT-P): It is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).

  At baseline

• Absolute scores for FACT-P

  At week 12

• Absolute scores for FACT-P

  At week 16

• Absolute scores for FACT-P

  At week 24

• Absolute scores for FACT-P

  At week 28

• Absolute scores for EORTC QLQ-PR25

  European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Specific module (EORTC QLQ-PR25): It is a questionnaire with score calculation is by subscales: urinary symptoms, bother due to use of incontinence aid, bowel symptoms, hormonal treatment-related symptoms, sexual activity and sexual functioning. Absolute score \[scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).

  At baseline

• Absolute scores for EORTC QLQ-PR25

  At week 12

• Absolute scores for EORTC QLQ-PR25

  At week 16

• Absolute scores for EORTC QLQ-PR25

  At week 24

• Absolute scores for EORTC QLQ-PR25

  At week 28

Secondary Outcomes (14)

• 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

• 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

• 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

Study Arms (1)

Radium-223-dichloride (Xofigo, BAY88-8223)

Patients with metastatic castration-resistant prostate cancer (mCRPC)

Drug: Radium-223-dichloride (Xofigo, BAY88-8223)

Interventions

Radium-223-dichloride (Xofigo, BAY88-8223) DRUG

Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice

Radium-223-dichloride (Xofigo, BAY88-8223)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colombian patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Colombia

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Prostatic Neoplasms; Bone Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 23, 2020
• Study Start: April 8, 2021
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)