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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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) .

Conditions
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Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: Coenzyme A Combined With Abiraterone
* Drug: Abiraterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Coenzyme A 200U<br>Coenzyme A 200U per day | Drug: Coenzyme A Combined With Abiraterone<br>* Abiraterone 4 pieces per day. Coenzyme A 200U<br>|
| Placebo Comparator: Placebo Comparator: Placebo<br>Abiraterone without coenzyme A | Drug: Abiraterone<br>* Abiraterone<br>|

What is the study measuring?
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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 |