Overview

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.