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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR4035 | Other Identifier | Janssen Research & Development, LLC |
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The protocol was cancelled due timelines be not compatible with business strategy in Colombia.
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The primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a real-world clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCRPC participants | Participants will not receive any intervention as a part of this study. Participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have adequate response to treatment (abiraterone Acetate + prednisone) will be observed to collect data for ECOG performance status, safety assessments (as described above), the collection of PROs (BPI-short form, Pain VAS, HCU questionnaire), the assessment of disease status and parameters, and the assessment of participant compliance to treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Complaint With Treatment (Compliance Rate) | Percentage of participants who are compliant to abiraterone acetate and prednisone (AA + P) treatment in Colombian mCRPC participants experiencing adequate response to treatment will be assessed. | Month 12/ early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P | Treatment suspension will be defined as the interruption of drug administration (abiraterone acetate) for two or more cycles of administration. | Month 12/ early withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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Participants enrolled in this study will be men with mCRPC currently receiving AA + P for at least 1 cycle before study enrollment, and to a maximum of 4 cycles (4 months).
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Abandonment of mCRPC Participants Treated With AA + P |
Treatment abandonment will be defined as patient-driven cessation of drug administration, regardless of causality. |
| Month 12/ early withdrawal |
| Utilization of Health Care Resources, as Measured by the Consumption of Health Care Resources Questionnaire | Utilization of Health Care Resources will be measured by the Consumption of Health Care Resources Questionnaire, which includes questions related to the participant's use of health care resources related to Prostate cancer PCa: 1) Insurance type, 2) Extra or unscheduled visits to the study doctor, another physician/specialist, healthcare professional (like nurse, therapist, physiotherapist), 3) Admission to a hospital, 4) Visits to a hospital emergency room, 5) Use of an ambulance service, 6) Complementary alternative therapy visits. | Baseline, Months 3, 6, 9, 12/ early withdrawal |
| Change From AA + P Treatment Initiation in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Baseline, Months 3, 6, 9, and 12 | ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. | AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal |
| Change From AA + P Treatment Initiation in Prostate-Specific Antigen (PSA) Levels at Baseline, Months 3, 6, 9, and 12 | AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal |
| Change From AA + P Treatment Initiation in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Baseline, Months 3, 6, 9, and 12 | Pain intensity was assessed by Brief Pain Inventory Short Form (BPI-sf) on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine. | AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal |
| Change From AA + P Treatment Initiation in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Baseline, Months 3, 6, 9, and 12 | VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. | AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal |
| Change From Baseline in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Months 3, 6, 9, and 12 | ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. | Baseline, Months 3, 6, 9, 12/ early withdrawal |
| Change From Baseline in Prostate-Specific Antigen (PSA) Levels at Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12/ early withdrawal |
| Change From Baseline in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Months 3, 6, 9, and 12 | Pain intensity was assessed by Brief Pain Inventory Short Form (BPI-sf) on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine. | Baseline, Months 3, 6, 9, 12/ early withdrawal |
| Change From Baseline in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Months 3, 6, 9, and 12 | VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. | Baseline, Months 3, 6, 9, 12/ early withdrawal |
| Overall Survival (OS) | The OS is defined as the time from the date of first dose of study drug to date of death from any cause. | Month 12 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |