The Effects of Polaprezinc Combined With AR-inhibitors on Patients With CRPC

• Status: Enrolling by invitation
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangnan University
• Collaborator: Affiliated Hospital of Jiangnan University
• Treatments: Polaprezinc

Criteria

Inclusion Criteria:

• 1. 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.