Clinical trial · Observational
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Exposed to Abiraterone Acetate (TOGETHER)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The protocol was cancelled due timelines be not compatible with business strategy in Colombia.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- mCRPC participants
- description
- 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.
Primary outcomes (1)
- measure
- Percentage of Participants Complaint With Treatment (Compliance Rate)
- timeFrame
- Month 12/ early withdrawal
- description
- 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.
Secondary outcomes (12)
- measure
- Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Distant metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI) * Prescribed and currently (at enrollment) being treated with abiraterone acetate and prednisone (AA + P) for the treatment of Castration-resistant metastatic prostate cancer (mCRPC) according to the local product label * Having received a minimum 1 cycle of AA + P (4 weeks), and maximum 4 consecutive cycles of AA + P (16 weeks ) prior to study enrollment * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 at enrollment Exclusion Criteria: * Participants who have received and terminated abiraterone acetate treatment for prostate cancer (PCa) in the past * Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device less than or equal to (\<=) 30 days before the start of the study or the first data collection time point * Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the abiraterone acetate treatment in mCRPC * Known brain metastases * Pathological finding consistent with small cell carcinoma of the prostate
References
Publications (0)
Data not yet available