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 (QOLRAD)

• ClinicalTrials.gov Identifier: NCT04681144
• Recruitment Status: Recruiting
• First Posted: December 23, 2020
• Last Update Posted: February 23, 2023
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Prostate Cancer	Drug: Radium-223-dichloride (Xofigo, BAY88-8223)

Study Design

• Study Type: Observational
• Estimated Enrollment: 105 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Describing the Quality Of Life in Colombian Patients mCRPC Under Treatment With RADium-223.
• Actual Study Start Date: April 16, 2021
• Estimated Primary Completion Date: February 15, 2024
• Estimated Study Completion Date: February 15, 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Radium-223-dichloride (Xofigo, BAY88-8223); Patients with metastatic castration-resistant prostate cancer (mCRPC)	Drug: Radium-223-dichloride (Xofigo, BAY88-8223); Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice

Outcome Measures

Primary Outcome Measures :

1. Absolute scores for FACT-P [ Time Frame: At baseline ]
   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).
2. Absolute scores for FACT-P [ Time Frame: At week 12 ]
3. Absolute scores for FACT-P [ Time Frame: At week 16 ]
4. Absolute scores for FACT-P [ Time Frame: At week 24 ]
5. Absolute scores for FACT-P [ Time Frame: At week 28 ]
6. Absolute scores for EORTC QLQ-PR25 [ Time Frame: At baseline ]
   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).
7. Absolute scores for EORTC QLQ-PR25 [ Time Frame: At week 12 ]
8. Absolute scores for EORTC QLQ-PR25 [ Time Frame: At week 16 ]
9. Absolute scores for EORTC QLQ-PR25 [ Time Frame: At week 24 ]
10. Absolute scores for EORTC QLQ-PR25 [ Time Frame: At week 28 ]

Secondary Outcome Measures :

1. Absolute scores for Physical Well Being, Social/Family Well Being, Emotional Well Functional Well Being, in the FACT-P [ Time Frame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection ]
2. Absolute scores for urinary and bowel symptoms, sexual activity and function, and adverse effects to treatments in the EORTC QLQ-PR25 [ Time Frame: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection ]
3. Absolute scores for FACT-P; according to number of Radium-223 cycles [ Time Frame: 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.
4. Absolute scores for EORTC QLQ-PR25; according to number of Radium-223 cycles [ Time Frame: 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.
5. Absolute scores for FACT-P; according line of treatment [ Time Frame: 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.
6. Absolute scores for EORTC QLQ-PR25; according line of treatment [ Time Frame: 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.
7. Absolute scores for FACT-P; according to prior use or chemotherapy [ Time Frame: 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
8. Absolute scores for EORTC QLQ-PR25; according to prior use or chemotherapy. [ Time Frame: 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
9. Absolute scores for FACT-P; according to clinical characteristics. [ Time Frame: 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).
10. Absolute scores for EORTC QLQ-PR25; according to clinical characteristics. [ Time Frame: 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).
11. Absolute scores for FACT-P; according to changes in PSA. [ Time Frame: 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
12. Absolute scores for EORTC QLQ-PR25; according to changes in PSA [ Time Frame: 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
13. Absolute scores for FACT-P; according to changes in ALP level [ Time Frame: 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
14. Absolute scores for EORTC QLQ-PR25; according to changes in ALP level [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Contacts

Contact: Bayer Clinical Trials Contact; (+)1-888-84 22937; clinical-trials-contact@bayer.com

Locations

Colombia

Many Locations; Recruiting

Multiple Locations, Colombia

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04681144
• Other Study ID Numbers: 21517
• First Posted: December 23, 2020
• Last Update Posted: February 23, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

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

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Radium Ra 223 dichloride; Antineoplastic Agents