NCT04839055

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) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

14 days

First QC Date

April 8, 2021

Last Update Submit

April 8, 2021

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

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.

    2 weeks

Study Arms (2)

Experimental: Coenzyme A 200U

EXPERIMENTAL

Coenzyme A 200U per day

Drug: Coenzyme A Combined With Abiraterone

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Abiraterone without coenzyme A

Drug: Abiraterone

Interventions

Coenzyme A Combined With AbirateroneDRUG

Abiraterone 4 pieces per day. Coenzyme A 200U

Experimental: Coenzyme A 200U
AbirateroneDRUG

Abiraterone

Placebo Comparator: Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Interventions

abiraterone

Study Officials

  • YongQuan Chen, MD

    Jiangnan University

    STUDY CHAIR

Central Study Contacts

YongQuan Chen, MD

CONTACT

051013812517168yqchen@jiangnan.edu.cn

Rong Wang, EM

CONTACT

051018652457101840174458@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 9, 2021

Study Start

March 18, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations

CN(1)