Clinical trial · Observational
A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer
A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1
- description
- Subjects with biochemical failure experience after primary treatment and have high-risk disease
- label
- Cohort 2
- description
- Subjects with a medical diagnosis of castration-resistant prostate cancer
- label
- Cohort 3
- description
- Subjects with an initial diagnosis of metastatic prostate cancer
Primary outcomes (2)
- measure
- Patterns of disease management
- timeFrame
- up to 72 months
- description
- Description of disease assessment methods, physician referral patterns and treatments
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of prostate adenocarcinoma * Will receive a new intervention at the time of study entry, for the treatment of: * Biochemical failure after initial curative-intent surgery (radical prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy, or both) and a PSA doubling time of one year or less or a confirmed PSA of ≥ 50 ng/mL (2 consecutive values) within 6 months prior to study entry; or * Castration-resistant prostate cancer; or * Metastatic prostate cancer at initial diagnosis of prostate cancer Exclusion Criteria: * Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy * Life expectancy of \<1 year due to comorbidities
References
Publications (0)
Data not yet available