Clinical trial · Interventional
Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC
Safety and Efficacy of the Stomach Ulcer Drug Polaprezinc (POL) on Enzalutamide- or Abiraterone-resistant CRPC
NCT05549778CI-TRIAL-00067909PEACecompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 evaluate clinical safety and efficacy of a gastric ulcer drug, polaprezinc (POL), with the AR-inhibitor abiraterone in Chinese patients with castration-resistant prostate cancer (CRPC).
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 |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Drug | — | UNRESOLVED |
| Polaprezinc group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Polaprezinc group
- description
- Patients will be on abiraterone plus polaprezinc (75 mg b.i.d. for 6 months)
- interventionNames
- Drug: Polaprezinc group
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Patients will be on abiraterone, radiotherapy or chemotherapy for 6 months
- interventionNames
- Drug: Control group
Primary outcomes (2)
- measure
- PSA response
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients were older than 18 years of age. 2. Patients with measurable disease were required to have documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) (28) with at least one bone metastatic lesion. Patients with non-measurable disease were required to have at least two consecutive increases (relative to a reference value measured at least a week apart) in serum PSA. 3. Patients had been taking abiraterone or enzalutamide for at least three consecutive months and showed a persistent rise in PSA. 4. Life expectancy \>6 months Exclusion Criteria: 1. Patients had taken polaprezinc previously. 2. Patients had cancer therapy (other than ADT) within 4 weeks before enrolment. 3. Patients had malignancies other than prostate cancer. 4. Patients had uncontrolled severe illness or medical conditions.
References
Publications (0)
Data not yet available
No reference posted for this study.