Prostate CancerQOLRADNCT04681144
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
An observational study of Prostate Cancer, run by Bayer at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radium-223-dichloride (Xofigo, BAY88-8223)
- How many people
- 103 participants
- Where
- 1 siteColombia
- Study dates
- 8 Apr 2021to 21 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Colombian patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
Who may be able to join
- 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).
Who cannot join
- Patients with contraindications to the use of Radium-223 according to the local label.
- Patients and who refused to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Describing the Quality Of Life in Colombian Patients mCRPC Under Treatment With RADium-223.
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.
Read more
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
- Being tested
- Radium-223-dichloride (Xofigo, BAY88-8223)
- Keywords
- Bone metastatic castration resistant prostate cancer, Radium-223, mCRPC, Phase IV, Advance prostate cancer, Quality of life, Bone Cancer
- Medical subject headings
- Prostatic Neoplasms, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223-dichloride (Xofigo, BAY88-8223)Drug
Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice
| Study group | Role | What they receive |
|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223) | Patients with metastatic castration-resistant prostate cancer (mCRPC) Receives: Drug: Radium-223-dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline
Absolute scores for FACT-P
Measured: At week 12
Absolute scores for FACT-P
Measured: At week 16
Absolute scores for FACT-P
Measured: At week 24
Absolute scores for FACT-P
Measured: 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).
Measured: At baseline
Absolute scores for EORTC QLQ-PR25
Measured: At week 12
Absolute scores for EORTC QLQ-PR25
Measured: At week 16
Absolute scores for EORTC QLQ-PR25
Measured: At week 24
Absolute scores for EORTC QLQ-PR25
Measured: 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
Measured: 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
Measured: 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
Number of cycles of Radium-223 will be measured as total number of doses received.
Measured: 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
Number of cycles of Radium-223 will be measured as total number of doses received.
Measured: 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
Line of treatment is classified as first , second or third line agent according to formulation scheme.
Measured: 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 line of treatment
Line of treatment is classified as first , second or third line agent according to formulation scheme.
Measured: 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 prior use or chemotherapy
Patients will be classified as prior chemotherapy or chemotherapy naïve
Measured: 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 prior use or chemotherapy.
Patients will be classified as prior chemotherapy or chemotherapy naïve
Measured: 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 clinical characteristics.
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).
Measured: 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 clinical characteristics.
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).
Measured: 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 changes in PSA.
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
Measured: 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 changes in PSA
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
Measured: 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 changes in ALP level
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
Measured: 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 changes in ALP level
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
Measured: Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start8 Apr 2021
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681144
- Sponsor's protocol ID
- 21517
- Acronym
- QOLRAD
- Status last verified
- Aug 2023
- First submitted
- 4 Dec 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing the Quality Of Life in Colombian Patients mCRPC Under Treatment With RADium-223.
- ClinicalTrials.gov ID
- NCT04681144
- Acronym / sponsor ID
- QOLRAD / 21517
- Conditions
- Prostate Cancer
- Keywords
- Bone metastatic castration resistant prostate cancer, Radium-223, mCRPC, Phase IV, Advance prostate cancer, Quality of life, Bone Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223) | – | Drug: Radium-223-dichloride (Xofigo, BAY88-8223)Patients with metastatic castration-resistant prostate cancer (mCRPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colombian patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients with contraindications to the use of Radium-223 according to the local label.
- Patients and who refused to sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223)Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice | Drug | Radium-223-dichloride (Xofigo, BAY88-8223) |
Primary outcome
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).
Absolute scores for FACT-P
Time frame: At week 12
Absolute scores for FACT-P
Time frame: At week 16
Absolute scores for FACT-P
Time frame: At week 24
Absolute scores for FACT-P
Time frame: At week 28
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).
Absolute scores for EORTC QLQ-PR25
Time frame: At week 12
Absolute scores for EORTC QLQ-PR25
Time frame: At week 16
Absolute scores for EORTC QLQ-PR25
Time frame: At week 24
Absolute scores for EORTC QLQ-PR25
Time frame: At week 28
14 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Bayer at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute scores for FACT-P (time frame: At baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.