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

Castration-resistant Prostate Cancer Clinical Trial

— CoA-CRPC  

Official title:

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) .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839055
• Other study ID #: JiangnanU RWang-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 18, 2021
• Est. completion date: May 2021

Study information

• Verified date: April 2021
• Source: Jiangnan University
• Contact: YongQuan Chen, MD
• Phone: 051013812517168
• Email: yqchen[@]jiangnan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Coenzyme A Combined With Abiraterone
Abiraterone 4 pieces per day. Coenzyme A 200U
• Abiraterone
Abiraterone

Locations

Country	Name	City	State
China	Jiangnan University	Wuxi	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangnan University	Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total prostate specific antigen (TPSA) level	The primary efficacy variable from 12.82 ng/mL to 13.01 ng/mL in serum TPSA level and 2 weeks of treatment.	2 weeks