Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC (PEACe)

Safety and Efficacy of the Stomach Ulcer Drug Polaprezinc (POL) on Enzalutamide- or Abiraterone-resistant CRPC

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).

Study Overview

• Status: Completed
• Conditions: Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Polaprezinc group; Drug: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214000
      • Jiangnan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polaprezinc group; Patients will be on abiraterone plus polaprezinc (75 mg b.i.d. for 6 months)	Drug: Polaprezinc group; Abiraterone plus Polaprezinc for 6 months; Other Names: POL
Active Comparator: Control group; Patients will be on abiraterone, radiotherapy or chemotherapy for 6 months	Drug: Control group; Abiraterone, radio- or chemotherapy; Other Names: OTH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA response	Decrease in PSA level or slowdown in PSA progression	6 months
Disease progression	Non-progressive disease (Non-PD) by ECT imaging analysis according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria	6 months

Collaborators and Investigators

• Sponsor: Jiangnan University
• Collaborators: Affiliated Hospital of Jiangnan University
• Investigators: Principal Investigator: Yong Q Chen, MD/PHD, Jiangnan University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: CRPC; POL
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Gastrointestinal Agents; Anti-Ulcer Agents; Polaprezinc
• Other Study ID Numbers: JiangnanU RWang-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No