Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC

What Was Tested

This registered phase 1, phase 2 trial tested Carnosine.

It had two arms (groups): Polaprezinc group (experimental) and Control group (active comparator).

Patients will be on abiraterone, radiotherapy or chemotherapy for 6 months.

The registry classes the interventions as drug.

More on the Plan

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.

The primary mechanisms of POL action are identified as anti-inflammatory and antioxidant pathways.

Who Took Part

The registry lists 12 actual participants took part.

It was open to men only aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male patients were older than 18 years of age. Life expectancy \>6 months.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients had taken polaprezinc previously; patients had cancer therapy (other than adt) within 4 weeks before enrolment; patients had malignancies other than prostate cancer.

How the Study Was Run

It was run as a non-randomized, parallel-group and double-blind study.

The Carnosine group and the comparison group ran side by side rather than switching.

As a double-blind Carnosine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2021-01-06 with completion listed for 2023-01-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PSA response (time frame: 6 months). Disease progression (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Carnosine in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.