The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC

NCT ID: NCT04839055

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2021-05-31

Brief Summary

The purpose of this study is to compare the therapy effects and clinical safety of a regulatory metabolic compound, coenzyme A (CoA) with a marketed drug, abiraterone, in Chinese patients with castration-resistant prostate cancer (CRPC) .

Detailed Description

Prostate Cancer (PCa) has developed into the second most common cancer in men. In The United States, PCa has the highest morbidity in man. In China, the incidence rate is lower than in Europe and the US, but it is growing faster and faster. Androgen deprivation therapy (ADT) has been the most commonly used treatment for men with advanced prostate cancer for hundreds of years, effective in more than 85 percent of cases, but usually after 20 months or so, half of patients will inevitably develop castration-resistant prostate cancer (CRPC), which will become resistant to ADT, and patients will relapse. There are several treatments that are trying to address this problem. Such as the chemotherapy docetaxel, cabataxel, and the radioactive drug radium 223 dichloride; PARP inhibitor olaparib, but the efficacy is limited.

For finding some new pathways and targets to treat CRPC, a model of PCa persister cell was first been established at a cellular level in this study. In light of the new target, we first find a being used clinically drug, Coenzyme A (CoA), through prescription sieve to treat enzalutamide or abiraterone drug-fast CRPC patients. CoA functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. There is an efficient drug action at a cellular level and in animals, and we look forward to it at clinical utility.

Conditions

Castration-resistant Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: Coenzyme A 200U

Coenzyme A 200U per day

Group Type: EXPERIMENTAL

Coenzyme A Combined With Abiraterone

Intervention Type: DRUG

Abiraterone 4 pieces per day. Coenzyme A 200U

Placebo Comparator: Placebo

Abiraterone without coenzyme A

Group Type: PLACEBO_COMPARATOR

Abiraterone

Intervention Type: DRUG

Abiraterone

Interventions

Coenzyme A Combined With Abiraterone

Abiraterone 4 pieces per day. Coenzyme A 200U

Intervention Type: DRUG

Abiraterone

Abiraterone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18-100 years of age combined use with abiraterone or enzalutamide CRPC

Exclusion Criteria

• pregnancy acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit primary hypothyroidism psychiatric patients poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg using contraceptive agent using immunosuppressive drugs, prohibited medication or other non-PCa drugs long-term using CoA drug

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

Sponsors

Jiangnan University

OTHER

Sponsor Role: lead

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YongQuan Chen, MD

Role: STUDY_CHAIR

Jiangnan University

Locations

Jiangnan University

Wuxi, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

YongQuan Chen, MD

Role: CONTACT

yqchen@jiangnan.edu.cn

051013812517168

Rong Wang, EM

Role: CONTACT

840174458@qq.com

051018652457101

Facility Contacts

YongQuan Chen, MD

Role: primary

yqchen@jiangnan.edu.cn

051013812517168

rong wang, EM

Role: backup

W0826R@outlook.com

051018652457101

Other Identifiers

JiangnanU RWang-1

Identifier Type: -

Identifier Source: org_study_id