POL-CRPC: The Effects of Polaprezinc Combined With AR-inhibitors on Patients With CRPC
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the therapy effects and clinical safety of a gastric ulcer, polaprezinc (POL) with a marketed AR-inhibitors, abiraterone, enzalutamide, or darolutamimde in Chinese patients with castration-resistant prostate cancer (CRPC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Prostate Cancer (PCa) has developed into the second most common cancer in men. In The United States, PCa has the highest morbidity in man. In China, the incidence rate is lower than in Europe and the US, but it is growing faster and faster. Androgen deprivation therapy (ADT) has been the most commonly used treatment for men with advanced prostate cancer for hundreds of years, effective in more than 85 percent of cases, but usually after 14-18 months, patients will inevitably develop castration-resistant prostate cancer (CRPC), which will become resistant to ADT, and patients will relapse. There are several treatments that are trying to address this problem. Such as the chemotherapy docetaxel, cabataxel, and the radioactive drug radium 223 dichloride; PARP inhibitor olaparib, but the efficacy is limited.
For finding some new pathways and targets to treat CRPC, a model of PCa persister cell was first been established at a cellular level in this study. In light of the new target, we first find a being used clinically drug, polaprezinc (POL), through prescription sieve to treat enzalutamide, abiraterone, or darolutamide drug-resistant CRPC patients. Zinc-L-carnosine (ZnC), also called polaprezinc (otherwise known as PepZin GI™), is a chelated compound that contains L-carnosine and zinc. It is a relatively new molecule and has been associated with multiple health benefits. Some reports indicated that POL is effective in restoring the gastric lining, healing other parts of the gastrointestinal (GI) tract, improving taste disorders, improving GI disorders, and enhancing skin and liver. The primary mechanisms of POL action are identified as anti-inflammatory and antioxidant pathways. There is an efficient drug action at a cellular level and in animals, and we look forward to it at clinical utility.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: polaprezinc experimental group Abiraterone and 2 bags (75 mg per bag) polaprezinc per day for 6 months |
Drug: Polaprezinc
polaprezinc group
Other Names:
Drug: Abiraterone
only abiraterone group
Other Names:
|
| Placebo Comparator: placebo comparison group Abiraterone without polaprezinc |
Drug: Abiraterone
only abiraterone group
Other Names:
|
Outcome Measures
Primary Outcome Measures
- TPSA level [6 months]
total prostate specific antigen (TPSA) level
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Patients with measurable disease were required to have documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) with at least one visceral or soft-tissue metastatic lesion (characterization of mCRPC). Patients with non-measurable disease were required to have rising serum prostate-specific antigen (PSA) concentrations (at least two consecutive increases relative to a reference value measured at least a week apart) (characterization of biochemical recurrence) or the appearance of at least one new demonstrable radiographic lesion. 2. Eligible patients had been taking Abiraterone or Enzalutamide for three consecutive months before enrolment, and the PSA concentrations showed a persistent rise. 3. Enrolled patients take Polaprezinc Granules (purchased from the Affiliated Hospital of Jiangnan University), 2 bags (75 mg per bag) per day for 6 months, and PSA was measured and recorded every month. ECT or PET-CT were taken before and after enrollment.
Exclusion Criteria:
- Patients who had previous polaprezinc therapy, radiotherapy to 40% or more of the bone marrow, or cancer therapy within 4 weeks before enrolment were excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jiangnan University | Wuxi | Jiangsu | China | 214000 |
Sponsors and Collaborators
- Jiangnan University
- Affiliated Hospital of Jiangnan University
Investigators
- Principal Investigator: YongQuan Chen, MD, Jiangnan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JiangnanU RWang-2