Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC

NCT05549778 | Completed Phase 1 DMC

• 1 other identifier: JiangnanU RWang-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Castration-resistant Prostate Cancer

Keywords

CRPC; POL

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Polaprezinc group

EXPERIMENTAL

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

Drug: Polaprezinc group

Control group

ACTIVE COMPARATOR

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

Drug: Control group

Interventions

Polaprezinc group DRUG

Abiraterone plus Polaprezinc for 6 months

Also known as: POL

Polaprezinc group

Control group DRUG

Abiraterone, radio- or chemotherapy

Also known as: OTH

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients were older than 18 years of age.
• 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.
• Patients had been taking abiraterone or enzalutamide for at least three consecutive months and showed a persistent rise in PSA.
• Life expectancy \>6 months

You may not qualify if:

• Patients had taken polaprezinc previously.
• Patients had cancer therapy (other than ADT) within 4 weeks before enrolment.
• Patients had malignancies other than prostate cancer.
• Patients had uncontrolled severe illness or medical conditions.

Sponsors & Collaborators

• Jiangnan University: lead
• Affiliated Hospital of Jiangnan University: collaborator

Study Sites (1)

Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yong Q Chen, MD/PHD

  Jiangnan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be on abiraterone/prednisone plus polaprezinc, or with other treatments according to patients'wishes in consultation with physicians.

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 22, 2022
• Study Start: January 6, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 31, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)