CClinicalTrials.gg
Status unknownNCT04839055CoA-CRPCUpdated Apr 9, 2021

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

A Phase 1/2 interventional study of Coenzyme A Combined With Abiraterone and Abiraterone in Castration-resistant Prostate Cancer, sponsored by Jiangnan University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-04-09.

Sponsored by Jiangnan University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
Male
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Study 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) .

Read the 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.

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Conditions studied

  • Castration-resistant Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 50 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Jiangnan University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Experimental: Coenzyme A 200U

    Coenzyme A 200U per day

    Drug: Coenzyme A Combined With Abiraterone

  • Placebo comparator
    Placebo Comparator: Placebo

    Abiraterone without coenzyme A

    Drug: Abiraterone

Interventions

  • DrugCoenzyme A Combined With Abiraterone

    Abiraterone 4 pieces per day. Coenzyme A 200U

  • DrugAbiraterone

    Abiraterone

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

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Study locations

1 of 1 sites recruiting
  • Jiangnan University
    Wuxi, Jiangsu 214000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04839055
Lead sponsor
Jiangnan University
Collaborators
Affiliated Hospital of Jiangnan University
Responsible party
Sponsor
First posted
Apr 9, 2021
Start date
Mar 18, 2021
Primary completion
Apr 1, 2021
Completion
May 2021 (estimated)
Last update
Apr 9, 2021

Study contacts

YongQuan Chen, MD
Contact
yqchen@jiangnan.edu.cn
051013812517168
Rong Wang, EM
Contact
840174458@qq.com
051018652457101
YongQuan Chen, MD
study chair · Jiangnan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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