The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC (CoA-CRPC)

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) .

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) .

Study Overview

• Status: Recruiting
• Conditions: Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Coenzyme A Combined With Abiraterone; Drug: Abiraterone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: YongQuan Chen, MD; Phone Number: 051013812517168; Email: yqchen@jiangnan.edu.cn
• Study Contact Backup: Name: Rong Wang, EM; Phone Number: 051018652457101; Email: 840174458@qq.com

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214000
      • Recruiting
      • Jiangnan University
      • Contact: YongQuan Chen, MD; Phone Number: 051013812517168; Email: yqchen@jiangnan.edu.cn
      • Contact: rong wang, EM; Phone Number: 051018652457101; Email: W0826R@outlook.com
      • Principal Investigator: YongQuan Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental: Coenzyme A 200U; Coenzyme A 200U per day	Drug: Coenzyme A Combined With Abiraterone; Abiraterone 4 pieces per day. Coenzyme A 200U
PLACEBO_COMPARATOR: Placebo Comparator: Placebo; Abiraterone without coenzyme A	Drug: Abiraterone; Abiraterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangnan University
• Collaborators: Affiliated Hospital of Jiangnan University
• Investigators: Study Chair: YongQuan Chen, MD, Jiangnan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2021
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (ACTUAL): April 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: JiangnanU RWang-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No