Castration-resistant Prostate CancerPhase 1/2PEACeNCT05549778
Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC
A Phase 1/2 study testing Polaprezinc group 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 evaluate clinical safety and efficacy of a gastric ulcer drug, polaprezinc (POL), with the AR-inhibitor 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?
- Polaprezinc group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2021to 31 Jan 2023
- 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
- Male patients were older than 18 years of age.
- Patients with measurable disease were required to have documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) (28) with at least one bone metastatic lesion. Patients with non-measurable disease were required to have at least two consecutive increases (relative to a reference value measured at least a week apart) in serum PSA.
- Patients had been taking abiraterone or enzalutamide for at least three consecutive months and showed a persistent rise in PSA.
- Life expectancy >6 months
Who cannot join
- Patients had taken polaprezinc previously.
- Patients had cancer therapy (other than ADT) within 4 weeks before enrolment.
- Patients had malignancies other than prostate cancer.
- Patients had uncontrolled severe illness or medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the Stomach Ulcer Drug Polaprezinc (POL) on Enzalutamide- or Abiraterone-resistant CRPC
The purpose of this study is to evaluate clinical safety and efficacy of a gastric ulcer drug, polaprezinc (POL), with the AR-inhibitor abiraterone in Chinese patients with castration-resistant prostate cancer (CRPC).
Read the detailed description
Prostate cancer (PCa) is a major disease that affects 14.1% male population worldwide with a 6.8% mortality rate in 2020 (https://gco.iarc.fr/). In China, the PCa incidence rate is lower than in Europe and the US but increases rapidly. Androgen deprivation therapy (ADT) has been the most used treatment for men with advanced prostate cancer for decades. Despite the initial favorable response, nearly all patients progress to castration-resistant prostate cancer (CRPC) and subsequently succumb to the disease within 1-3 years.
Zinc-L-carnosine (ZnC), also called polaprezinc (otherwise known as PepZin GI™), is a chelated compound that contains L-carnosine and zinc. Some reports indicated that POL is effective in restoring the gastric lining, healing other parts of the gastrointestinal (GI) tract, improving taste disorders, improving GI disorders, and enhancing skin and liver. The primary mechanisms of POL action are identified as anti-inflammatory and antioxidant pathways. We have identified PRDX5 as a therapeutic target and repurposed polaprezinc (POL) as its inhibitor for the treatment of CRPC.
CRPC patients will be enrolled with their fully informed consent. Patients will be on abiraterone/prednisone, abiraterone/prednisone plus polaprezinc granules, or with other treatments according to patients' wishes in consultation with physicians. Polaprezinc will be 75 mg b.i.d., for 6 months. A standard regimen will be used for other treatments. PSA will be measured every month. ECT will be taken before and after treatment.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Polaprezinc group, Control group
- Keywords
- CRPC; POL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polaprezinc groupDrug
Also called POL
Abiraterone plus Polaprezinc for 6 months
Control groupDrug
Also called OTH
Abiraterone, radio- or chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Polaprezinc group | Experimental | Patients will be on abiraterone plus polaprezinc (75 mg b.i.d. for 6 months) Receives: Drug: Polaprezinc group |
| Control group | Active comparator | Patients will be on abiraterone, radiotherapy or chemotherapy for 6 months Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response
Decrease in PSA level or slowdown in PSA progression
Measured: 6 months
Disease progression
Non-progressive disease (Non-PD) by ECT imaging analysis according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start6 Jan 2021
- Primary completion20 Jan 2023
- Study completion31 Jan 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be on abiraterone/prednisone plus polaprezinc, or with other treatments according to patients'wishes in consultation with physicians.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangnan University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University
- Responsible party
- Sponsor
- Investigators
- Yong Q Chen, MD/PHD, Principal investigator, Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549778
- Sponsor's protocol ID
- JiangnanU RWang-2
- Acronym
- PEACe
- Status last verified
- May 2023
- First submitted
- 18 Sep 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Stomach Ulcer Drug Polaprezinc (POL) on Enzalutamide- or Abiraterone-resistant CRPC
- ClinicalTrials.gov ID
- NCT05549778
- Acronym / sponsor ID
- PEACe / JiangnanU RWang-2
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- CRPC; POL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangnan UniversityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 22 Sep 2022 (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 evaluate clinical safety and efficacy of a gastric ulcer drug, polaprezinc (POL), with the AR-inhibitor abiraterone in Chinese patients with castration-resistant prostate cancer (CRPC).
Detailed description
Prostate cancer (PCa) is a major disease that affects 14.1% male population worldwide with a 6.8% mortality rate in 2020 (https://gco.iarc.fr/). In China, the PCa incidence rate is lower than in Europe and the US but increases rapidly. Androgen deprivation therapy (ADT) has been the most used treatment for men with advanced prostate cancer for decades. Despite the initial favorable response, nearly all patients progress to castration-resistant prostate cancer (CRPC) and subsequently succumb to the disease within 1-3 years.
Zinc-L-carnosine (ZnC), also called polaprezinc (otherwise known as PepZin GI™), is a chelated compound that contains L-carnosine and zinc. Some reports indicated that POL is effective in restoring the gastric lining, healing other parts of the gastrointestinal (GI) tract, improving taste disorders, improving GI disorders, and enhancing skin and liver. The primary mechanisms of POL action are identified as anti-inflammatory and antioxidant pathways. We have identified PRDX5 as a therapeutic target and repurposed polaprezinc (POL) as its inhibitor for the treatment of CRPC.
CRPC patients will be enrolled with their fully informed consent. Patients will be on abiraterone/prednisone, abiraterone/prednisone plus polaprezinc granules, or with other treatments according to patients' wishes in consultation with physicians. Polaprezinc will be 75 mg b.i.d., for 6 months. A standard regimen will be used for other treatments. PSA will be measured every month. ECT will be taken before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be on abiraterone/prednisone plus polaprezinc, or with other treatments according to patients'wishes in consultation with physicians.
| Arm | Type | Receives |
|---|---|---|
| Polaprezinc group | Experimental | Drug: Polaprezinc groupPatients will be on abiraterone plus polaprezinc (75 mg b.i.d. for 6 months) |
| Control group | Active comparator | Drug: Control groupPatients will be on abiraterone, radiotherapy or chemotherapy for 6 months |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients were older than 18 years of age.
- Patients with measurable disease were required to have documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) (28) with at least one bone metastatic lesion. Patients with non-measurable disease were required to have at least two consecutive increases (relative to a reference value measured at least a week apart) in serum PSA.
- Patients had been taking abiraterone or enzalutamide for at least three consecutive months and showed a persistent rise in PSA.
- Life expectancy >6 months
Key exclusion criteria (4 listed)
- Patients had taken polaprezinc previously.
- Patients had cancer therapy (other than ADT) within 4 weeks before enrolment.
- Patients had malignancies other than prostate cancer.
- Patients had uncontrolled severe illness or medical conditions.
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 |
|---|---|---|
| Polaprezinc groupAlso: POLAbiraterone plus Polaprezinc for 6 months | Drug | Polaprezinc group |
| Control groupAlso: OTHAbiraterone, radio- or chemotherapy | Drug | Control group |
Primary outcome
PSA response
Time frame: 6 months
Decrease in PSA level or slowdown in PSA progression
Disease progression
Time frame: 6 months
Non-progressive disease (Non-PD) by ECT imaging analysis according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Yong Q Chen, MD/PHD principal investigator
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 Polaprezinc group 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jul 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA response (time frame: 6 months). The study lists 2 primary outcomes in all. 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 11 Jul 2023.