Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC

NCT ID: NCT05549778

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2023-01-31

Brief Summary

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).

Detailed Description

Prostate cancer (PCa) is a major disease that affects 14.1% male population worldwide with a 6.8% mortality rate in 2020 (https://gco.iarc.fr/). In China, the PCa incidence rate is lower than in Europe and the US but increases rapidly. Androgen deprivation therapy (ADT) has been the most used treatment for men with advanced prostate cancer for decades. Despite the initial favorable response, nearly all patients progress to castration-resistant prostate cancer (CRPC) and subsequently succumb to the disease within 1-3 years.

Zinc-L-carnosine (ZnC), also called polaprezinc (otherwise known as PepZin GI™), is a chelated compound that contains L-carnosine and zinc. 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. We have identified PRDX5 as a therapeutic target and repurposed polaprezinc (POL) as its inhibitor for the treatment of CRPC.

CRPC patients will be enrolled with their fully informed consent. Patients will be on abiraterone/prednisone, abiraterone/prednisone plus polaprezinc granules, or with other treatments according to patients' wishes in consultation with physicians. Polaprezinc will be 75 mg b.i.d., for 6 months. A standard regimen will be used for other treatments. PSA will be measured every month. ECT will be taken before and after treatment.

Conditions

Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Polaprezinc group

Patients will be on abiraterone plus polaprezinc (75 mg b.i.d. for 6 months)

Group Type: EXPERIMENTAL

Polaprezinc group

Intervention Type: DRUG

Abiraterone plus Polaprezinc for 6 months

Control group

Patients will be on abiraterone, radiotherapy or chemotherapy for 6 months

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: DRUG

Abiraterone, radio- or chemotherapy

Interventions

Polaprezinc group

Abiraterone plus Polaprezinc for 6 months

Intervention Type: DRUG

Control group

Abiraterone, radio- or chemotherapy

Intervention Type: DRUG

Other Intervention Names

POL; OTH

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: collaborator

Jiangnan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong Q Chen, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

Jiangnan University

Locations

Jiangnan University

Wuxi, Jiangsu, China

Countries

China

Other Identifiers

JiangnanU RWang-2

Identifier Type: -

Identifier Source: org_study_id