check_circleStudy Completed

Prostate Cancer,

Bayer Identifier:

21517

ClinicalTrials.gov Identifier:

NCT04681144

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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.

Trial summary

Enrollment Goal
103
Trial Dates
April 2021 - November 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Colombia

Primary Outcome

  • 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).
    date_rangeTime Frame:
    At baseline
  • Absolute scores for FACT-P
    date_rangeTime Frame:
    At week 12
  • Absolute scores for FACT-P
    date_rangeTime Frame:
    At week 16
  • Absolute scores for FACT-P
    date_rangeTime Frame:
    At week 24
  • Absolute scores for FACT-P
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    At baseline
  • Absolute scores for EORTC QLQ-PR25
    date_rangeTime Frame:
    At week 12
  • Absolute scores for EORTC QLQ-PR25
    date_rangeTime Frame:
    At week 16
  • Absolute scores for EORTC QLQ-PR25
    date_rangeTime Frame:
    At week 24
  • Absolute scores for EORTC QLQ-PR25
    date_rangeTime Frame:
    At week 28

Secondary Outcome

  • Absolute scores for Physical Well Being, Social/Family Well Being, Emotional Well Functional Well Being, in the FACT-P
    date_rangeTime 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
    date_rangeTime 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
    Number of cycles of Radium-223 will be measured as total number of doses received.
    date_rangeTime 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
    Number of cycles of Radium-223 will be measured as total number of doses received.
    date_rangeTime 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
    Line of treatment is classified as first , second or third line agent according to formulation scheme.
    date_rangeTime 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
    Line of treatment is classified as first , second or third line agent according to formulation scheme.
    date_rangeTime 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
    Patients will be classified as prior chemotherapy or chemotherapy naïve
    date_rangeTime 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.
    Patients will be classified as prior chemotherapy or chemotherapy naïve
    date_rangeTime 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.
    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).
    date_rangeTime 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.
    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).
    date_rangeTime 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.
    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
    date_rangeTime 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
    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
    date_rangeTime 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
    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
    date_rangeTime 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
    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
    date_rangeTime Frame:
    Baseline, 12, 16, 24- and 28-weeks and follow up visit week 28; 4 weeks post last injection

Trial design

Describing the Quality Of Life in Colombian patients mCRPC under treatment with RADium-223.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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