Clinical trial · Observational
Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide
Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration
- 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)
Prospective, non-comparative, non-interventional, observational study to collect and analyse real life environment data on advanced prostate cancer patients receiving combination treatment of medical or surgical castration and bicalutamide according to routine medical practice in Croatia. The main aim is to evaluate change of PSA level and prescribing practices based on prostate cancer stage.
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 |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate change in PSA level following 4-9 months of bicalutamide therapy
- timeFrame
- PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)
Secondary outcomes (6)
- measure
- bicalutamide prescribing practice based on prostate cancer stage
- timeFrame
- 1 measure (at the time of bicalutamde th introduction)
- measure
- to evaluate PSA level after 4-12 weeks of bicalutamide therapy
- timeFrame
- PSA - 1 measures (1-3 m following bicalutamide)
- measure
- to asses time to disease progression based on PSA values
- timeFrame
- PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of advanced prostate cancer * Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks * Patients capable of signing ICF Exclusion Criteria: * Patients with hypersensitivity to bicalutamide * Patients on therapy with terfenadin, astemizol or cisapride * Participation in a clinical study during the last 30 days
References
Publications (0)
Data not yet available