Castration-resistant Prostate CancerPhase 1/2CoA-CRPCNCT04839055
The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC
A Phase 1/2 study testing Coenzyme A Combined With Abiraterone and Abiraterone in people with Castration-resistant Prostate Cancer, run by Jiangnan University at 1 site in China.
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) . Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- Coenzyme A Combined With Abiraterone and Abiraterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2021to May 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-100 years of age combined use with abiraterone or enzalutamide CRPC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangnan University
Wuxi, Jiangsu, 214000
YongQuan Chen, MD, 051013812517168, yqchen@jiangnan.edu.cn
rong wang, EM, 051018652457101, W0826R@outlook.com
About this study
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) .
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.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Coenzyme A Combined With Abiraterone, Abiraterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme A Combined With AbirateroneDrug
Abiraterone 4 pieces per day. Coenzyme A 200U
AbirateroneDrug
Abiraterone
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Coenzyme A 200U | Experimental | Coenzyme A 200U per day Receives: Drug: Coenzyme A Combined With Abiraterone |
| Placebo Comparator: Placebo | Placebo comparator | Abiraterone without coenzyme A Receives: Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start18 Mar 2021
- Primary completion1 Apr 2021
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangnan University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University
- Responsible party
- Sponsor
- Investigators
- YongQuan Chen, MD, Study chair, Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839055
- Sponsor's protocol ID
- JiangnanU RWang-1
- Acronym
- CoA-CRPC
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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) .
- ClinicalTrials.gov ID
- NCT04839055
- Acronym / sponsor ID
- CoA-CRPC / JiangnanU RWang-1
- Conditions
- Castration-resistant Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jiangnan UniversityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Coenzyme A 200U | Experimental | Drug: Coenzyme A Combined With AbirateroneCoenzyme A 200U per day |
| Placebo Comparator: Placebo | Placebo comparator | Drug: AbirateroneAbiraterone without coenzyme A |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-100 years of age combined use with abiraterone or enzalutamide CRPC
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme A Combined With AbirateroneAbiraterone 4 pieces per day. Coenzyme A 200U | Drug | Experimental: Coenzyme A 200U |
| AbirateroneAbiraterone | Drug | Placebo Comparator: Placebo |
Primary outcome
Total prostate specific antigen (TPSA) level
Time frame: 2 weeks
The primary efficacy variable from 12.82 ng/mL to 13.01 ng/mL in serum TPSA level and 2 weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YongQuan Chen, MD study chair
Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coenzyme A Combined With Abiraterone and Abiraterone in people with Castration-resistant Prostate Cancer, run by Jiangnan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YongQuan Chen, MD (051013812517168, yqchen@jiangnan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total prostate specific antigen (TPSA) level (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.